Important Safety Information
CAUTION: U.S. Federal law restricts this device for sale by or on the order of a physician
Prior to use, please see the complete eCoin Physician Manual for more information in Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operators Instructions
Indications for use
The eCoin Peripheral Neurostimulator is intended to be used to treat urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation.
The eCoin Peripheral Neurostimulator is contraindicated for the following patients:
• Poor Surgical Candidates: The eCoin should not be implanted in patients who are poor surgical candidates. Poor surgical candidates include those who have: • Open wounds or sores on the lower leg or foot • Had prior surgery in the implant area • Had previous, unhealed trauma in the implant area • Pitting edema (≥2+) in the lower leg • Venous disease/insufficiency in the lower leg • Arterial disease/insufficiency in the lower leg • Vasculitis or dermatologic conditions in the lower leg • Infections near the implantation site in the lower leg
• Patient cannot properly operate the Patient Controller Magnets and paper tape for use in the event of unintended or unwanted stimulation.
Diathermy Shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as diathermy) should not be used on patients implanted with the eCoin Peripheral Neurostimulator System. Diathermy can transmit energy through the implanted system, potentially causing tissue damage at the location of the implanted eCoin, potentially resulting in injury. Magnetic Resonance Imaging (MRI)
The eCoin Peripheral Neurostimulator is an MRI Conditional system. It is not safe to have a patient’s lower leg placed in an MRI machine. Refer to “eCoin MR Labeling” for more information. The Patient Controller magnet is MR Unsafe and should never enter an MRI room or facility. Non-clinical testing has demonstrated that the eCoin Peripheral Neurostimulator, Model UUI is MR Conditional. The patient having an eCoin-UUI implant can be safely scanned in an MR system meeting the following conditions: • Static magnetic field of 1.5 and 3.0 T • Device remains at least 20 cm from the edge of the scanner bore Heating by RF Fields – not tested When the patient is scanned with the device located outside the scanner bore, RF heating is not expected.
Image Artifact – not tested
Other Medical Procedures Medical procedures that may affect the eCoin System and should not be used in the implant area include: • Monopolar electrosurgery • Microwave and Radiofrequency (RF) ablation • Radiation therapy over the eCoin • Ultrasound or scanning equipment If electrosurgery must be used during other medical procedures, bipolar electrosurgery is favored and a 25 cm distance from the implant location should be kept. Monopolar electrosurgery should be avoided. If unavoidable, monopolar electrosurgery should be used in the lowest effective setting and the grounding pad should be placed as far away as possible from the eCoin and on the contralateral side. If a patient must undergo a procedure during which an electrical current is passed through the patient’s body, the eCoin System should be monitored. This can be done through patient feedback during the procedure (patient indicates discomfort or unexpected stimulation) and a device interrogation/programming procedure conducted by a Valencia Technologies representative after the procedure. Electromagnetic Interference (EMI) Electromagnetic interference is energy generated by equipment found at home, work, or in public that can interfere with the function of the eCoin Peripheral Neurostimulator System. The eCoin System includes features that provide protection from EMI so that most electrical devices encountered in a normal day are unlikely to affect the operation of the eCoin. While everyday electrical devices are unlikely to affect the eCoin, there are strong sources of EMI that may temporarily affect the operation of the eCoin, including anti-theft detectors found in retail stores. If patients encounter any of these electrical devices, they should walk as far away from the sides of the anti-theft detector when passing through.
At the Airport, Courthouses, etc.
If patients encounter walkthrough metal detectors or security archways, they should walk through at a normal pace. These detectors should not affect the eCoin. Hand-held security wands should be passed over the eCoin quickly and should not affect the eCoin. Full-body security scanners (millimeter wave scanners) are used by the Transportation Security Administration (TSA) and are considered safe in patients that have a stimulator. Patients should carry their patient identification card at all times and should have it available if TSA or other security personnel request it. Additionally, patients should minimize their exposure by not lingering in the immediate area of the security systems. Some anti-theft detectors may not be visible. If patients feel unwanted stimulation or pain, they should walk away from the area and anti-theft detectors or security scanners. If the unwanted stimulation does not cease, patients should be instructed to use the Patient Controller magnet to inhibit device stimulation.
The eCoin contains battery chemicals that could cause burns if the eCoin case were ruptured or pierced.
Effects on Other Implanted Devices
The effect of the eCoin Peripheral Neurostimulator System on the operation of other implanted devices, such as cardiac devices, other neurostimulators, and implantable drug pumps, is not known. In particular, if the eCoin is implanted close to one of these devices, they may have sensing problems and/or inappropriate device responses. Potential interference issues should be investigated before surgery by clinicians involved with both devices. The programming of the devices may need to be optimized to provide maximum benefit from both devices.
eCoin Interaction with Implanted Cardiac Devices
When a patient needs both an eCoin and an implanted cardiac device (for example, a pacemaker or defibrillator), interactions between the two devices should be discussed by the patients’ physicians involved with both devices (such as the cardiologist, electrophysiologist, urologist, and urogynecologist) beforesurgery. To reduce potential interference, the devices should be implanted on opposite sides of the body and as far away from each other as practical. The stimulation pulses produced by the eCoin may interact with cardiac devices that sense cardiac activity, and disrupt the functioning of the cardiac device. The pivotal clinical trial of the eCoin device excluded patients with pacemakers and implantable cardiac defibrillators (ICDs).
Implanting Clinicians should be trained and certified by Valencia Technologies on the implantation and use of the eCoin Peripheral Neurostimulator System.
Prescribing Clinicians should be experienced in the diagnosis and treatment of urgency urinary incontinence (UUI) and should be trained on the use of the eCoin Peripheral Neurostimulator System.
Use in Specific Populations
The safety and effectiveness of this therapy has not been established for: • Pregnant women • Patients under the age of 18 • Patients with progressive, systemic neurological diseases • Bilateral stimulation
Clinician or Trained Field Person Programming Full programming information and instructions can be found in the eCoin Technical Programming Manual and Tecsun PL-360 Technical Manual. Amplitude Adjustment – The precaution below should be taken to prevent sudden stimulation changes that lead to an uncomfortable jolting or shocking feeling:
• The stimulation amplitude should be slowly increased to maximum. Please wait at least 5 seconds after triggering the eCoin device before adjusting amplitude to assure complete ramp up.
Sensitivity to Stimulation – Some patients may be able to sense the telemetry signals associated with reprogramming.
Programmer Interaction with a Cochlear Implant – Patients with cochlear implants should keep the external portion of their cochlear implant as far from the external controller as possible to minimize unintended audible clicks or other sounds.
Programmer Interaction with Flammable Atmospheres – The external controller is not intended to be used in the presence of a flammable gas, and the consequences of using the external controller in such an environment is not known.
Programmer Interaction with Other Implanted Devices – When a patient has an eCoin and another active implanted device (for example, a pacemaker, defibrillator, or other neurostimulator), the RF signal used to program any of these devices may reset or reprogram the other devices.
Whenever the settings for these devices are changed, a clinician familiar with each device should check the program settings of each device before the patient is released (or as soon as possible). Patients should contact their physician immediately if they experience symptoms that are likely to be related to the devices or their medical condition. For the eCoin, confirmation of the correct amplitude setting should be completed by adjusting the amplitude to the device minimum and then returning to the previously programmed amplitude.
Telemetry Signal Disruption from EMI – The eCoin should not be programmed near equipment that may generate electromagnetic interference (EMI) as the equipment may interfere with the external controller’s ability to communicate with the eCoin. If EMI is suspected to be interrupting programming, the external controller and the eCoin should be moved away from the likely source of EMI.
Electromagnetic Interference (EMI)
Patients may encounter additional equipment that generates EMI. This equipment is unlikely to affect the eCoin if the patients follow these guidelines:
Bone Growth Stimulators – The external coils of bone growth stimulators should be kept at least 45 cm (18 in) away from the eCoin.
Dental Drills and Ultrasonic Probes – The drill or probe should be kept 15 cm (6 in) away from the eCoin. Electrolysis – The electrolysis wand should be kept at least 15 cm (6 in) away from the eCoin. Electromagnetic Field Devices – The following equipment or environments should be avoided or patients should exercise caution around: • Antenna of citizens band (CB) radio or ham radio • Electric arc welding equipment • Electric induction heaters such as those used in industry to bend plastic • Electric steel furnaces • High-power amateur transmitters • High-voltage areas (generally safe if outside the fenced area) • Linear power amplifiers • Magnetic degaussing equipment • Magnets or other equipment that generates strong magnetic fields • Microwave communication transmitters (generally safe if outside the fenced area) • Perfusion systems • Resistance welders • Television and radio transmitting towers (generally safe if outside the fenced area)
Laser Procedures – The laser should not be directed at the eCoin.
Psychotherapeutic Procedures – Equipment used for psychotherapeutic procedures may induce electrical currents which may cause heating at the eCoin electrodes and could result in tissue damage. Equipment that generates electromagnetic interference (e.g., electroconvulsive therapy, transcranial magnetic stimulation) during psychotherapeutic procedures have not been established as safe to operate in a patient with a neurostimulator. Induced electrical currents may cause heating, especially at the eCoin electrode site, resulting in tissue damage.
Radiation Therapy – eCoin operation may be affected by high-radiation exposure. Sources of high radiation should not be directed at the eCoin. eCoin damage due to high-radiation exposure may not be immediately evident, and exposure should be limited using appropriate measures, including shielding and adjusting the beam angle to avoid exposure to the eCoin.
Transcutaneous Electrical Nerve Stimulation (TENS) – TENS electrodes should not be placed in locations where the TENS current passes over the eCoin. Discontinue using TENS if it starts affecting the performance of the eCoin.
If a patient thinks that an EMI generating equipment or environment is affecting the function of their eCoin, the patient should: 1. Move away from the equipment or object. 2. Turn off the equipment or object (if possible). If the patient is unable to eliminate the interference or believes the interference has altered the effectiveness of their therapy, the patient should contact their clinician or trained field person.
Sources of strong EMI can result in the following: • Patient Injury, resulting from heating of the eCoin that causes damage to surrounding tissue • System Damage, which may require surgical replacement due to change in symptom control • Operation Changes to the eCoin, causing it to turn on or off or to reset the settings, resulting in loss of stimulation or return of symptoms, causing a need for reprogramming by the clinician or trained field person. • Unexpected Changes in Stimulation, leading to a sudden increase or change in stimulation, which may be experienced as a jolting or shocking sensation. While the sensation may be uncomfortable, the device would not be damaged nor would it cause direct injury to the patient. In rare cases, the change in stimulation may cause the patient to fall and be injured. If the patient experiences uncomfortable stimulation, they should be instructed to use the Patient Controller magnet to inhibit the stimulation output.
Activities Requiring Excessive Twisting or Stretching – Patient activities that may strain the implanted eCoin should be avoided for 8 weeks after implantation. For example, movements that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching of the foot, ankle, or leg may cause migration of the eCoin. eCoin migration may cause loss of stimulation or intermittent stimulation. Additional surgery may be required to replace or reposition the eCoin. Activities that typically involve these movements include gymnastics, mountain biking, and other vigorous sports. Clinicians should ask their patients about the activities in which they participate and inform them of the need for restricted activities during the first 8 weeks with the eCoin or until the clinician believes the implant and incision sites have healed enough to return to normal activities.
Component Manipulation by Patient (Twiddler’s Syndrome) – Clinicians should advise patients to refrain from manipulating the eCoin through the skin. Manipulation may cause device damage, device migration, skin erosion, or uncomfortable stimulation.
Scuba Diving or Hyperbaric Chambers – Pressures below 8 meters (25 feet) of water (or above 150 kPa) could damage the eCoin. Diving below 8 meters (25 feet) of water or entering hyperbaric chambers above 150 kPa should be avoided. Patients should discuss the effects of high pressure with their physician before diving or using a hyperbaric chamber.
Skydiving, Skiing, or Hiking in the Mountains – High altitudes should not affect the eCoin as long as absolute atmospheric pressure remains above 70 kPa (approximately 10,000 feet above sea level). Patients should be cautious with strenuous activities due to the potential for movements that may put stress on the implanted eCoin. For example, a sudden slip or step while hiking may cause migration, which may require surgery to replace or remove the eCoin.
Unexpected Changes in Stimulation – A perceived increase in stimulation may be caused by electromagnetic interference, postural changes, and other activities. Some patients may find this uncomfortable (a jolting or shocking feeling). Before engaging in activities during which receiving a jolt would be unsafe for the patient or those around them, patients should discuss lowering the stimulation amplitude or turning the eCoin off with their clinician or trained field person. Patients should also be instructed on how to use the Patient Controller magnet in the event of unwanted or painful stimulation.
eCoin Packaging – Any eCoin that has been compromised in any way should not be implanted. Do not implant the eCoin if any of the following have occurred: • The storage package or sterile package has been damaged, pierced, or altered, as sterility cannot be guaranteed, which may lead to infection. • The eCoin itself shows any signs of damage. The eCoin may not function properly. • The use-by date has expired. In this case, eCoin sterility cannot be guaranteed and infection may occur. • The sterile eCoin was dropped onto a non-sterile surface. In this case, the sterility cannot be guaranteed and infection may occur.
Shipping and Storage Environment:
The following lists the appropriate temperature conditions for shipping and storing the eCoin: • Temperature (short term): -10°C to 55°C • Temperature (long term): 10°C to 40°C • Pressure: 70kPa to 150kPa • Ambient humidity If the eCoin is exposed to extreme temperatures, it may be permanently damaged and should not be used, even if it has returned to a temperature that is within the specified operating range.
The contents of this package have been sterilized using ethylene oxide gas. This device is for single use only and should not be re-sterilized.
eCoin Peripheral Neurostimulator System Implant
eCoin Failures – There is a possibility that the eCoin may fail. Failures such as electrical shorts, open circuits, and insulation breaches may occur. Also, the eCoin battery will eventually deplete. The eCoin should provide at least 1 year of service with a high degree of stimulation. Depending on amplitude settings, the battery will have a lifespan of 1-8 years. When the eCoin battery becomes depleted, the eCoin will need to be replaced.
eCoin Handling –The eCoin must be handled with extreme care. It may be damaged by excessive force or sharp instruments, which can lead to intermittent stimulation or loss of stimulation altogether and may require surgery to replace.
Potential Adverse Events Summary
Implantation and use of the eCoin Peripheral Neurostimulator System incurs risk beyond those normally associated with surgery, some of which may necessitate intervention. In addition to the risks listed, there is a risk that eCoin therapy may not be effective in relieving symptoms or may cause worsening of symptoms. These risks include, but are not limited to the following:
Risks associated with the eCoin placement procedure: • Pain • Infection • Seroma • Hematoma • Abscess • Wound dehiscence • Edema at the implant or incision site • Iatrogenic injury to nearby nerves, vessels, or tendons • Complications associated with the local anesthetic used during the procedure • Blisters associated with the aftercare materials (ankle wrap) • Patient use of anticoagulation therapies may increase the risk of procedure-related complications, such as hematomas.
Risks associated with the use of the eCoin system: • Adverse change in storage and/or voiding function (bowel or bladder) • Device migration • Device inversion or extrusion • Allergic response or tissue reaction to the implanted system material • Hematoma or seroma at the implant or incision site • Skin erosion at the implant or incision site • Persistent pain at the implant or incision site • Tissue damage at the implant site • Device toxicity effects and burns at the implant site • Premature battery depletion • Loss of therapeutic effect over time • Uncomfortable or changed stimulation sensation • Unintended stimulation •Reduced stimulation caused by a depleting battery • Nerve injury • Device failure • Need for reoperation or revision