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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient said their equipment can't synch so that they can recharge their ins.Pt said they have not yet gone back for their follow-up appointment and their incision was not yet healed.Reviewed it is recommended waiting to recharge until after the implant site is healed and their doctor has cleared them to start to recharge.Troubleshooting was unable to be performed, patient services offered to help pt use the handset and communicator to check the ins battery level and pt said it was plugged into ac power and they wanted to let it finish charging and pt will call back if they need assistance, once it is recharged.Additional information was received from the patient.They reported that the patient was having issues getting the recharger to connect.The patient (pt) initiated a charging session on the call.It was initially showing 3167 error code.After bypassing this the recharger continues to show searching.The patient confirmed they think they were right over the implant but stated later they were doing this over their clothing.Patient services recommended charging while sitting and crossing leg and leaning over.Patient services had pt try moving 2cm in each direction and holding recharger there for at least 30 seconds.Pt mentioned getting 1707 code and when they tried to bypass it, it showed recharger is inactive.The patient closed out of all apps and restarted the phone and the recharger.Once completed, the pt continued to see 1707 and "recharger inactive".Patient services had pt put recharger in dock and pt confirmed that the recharger was 100% full.The patient tried to initiate a charging session one more time and saw that it was charging and the implant was at 0% but it immediately went back to searching.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the manufacturer's representative.On may 21st the rep was with the patient and she said s he placed the wireless recharger(wr) on patient and every time the system connects to the implant but then would disconnect shortly after.Technical services(ts) had rep separate the wr into 4 quadrants and then tried each section; the section that worked the best is near the top of the recharger, near the part where the power cord plugs into the dock.Patient got excellent quality and it maintained for a few minutes before disconnecting and then reconnecting again.Assessment of the pocket, rep thinks the implant is at about 1 half inch, she "thinks" she can feel all four corners.Ts told rep that it's not likely the recharger being a problem, since it connects at one point, but rather likely the positioning and depth of the implant.Rep plans to try another recharger that she has and if the result is the same then she'll request x-ray to determine implant depth and position.Rep had extra recharger with her but they didn't have a charge on it.Rep also mentioned seeing error 4100, but that is normal since rep turned the recharger off, thus the wireless application isn't going to find the recharger.On may 24th the rep stated the cause of the difficulty maintaining connection to recharge was determined to be due to positioning of recharger and device.They found location where they were able to get a full recharge.And sent the patient home with markings to show her caregiver where the recharger should be placed.Rep was unsure whether patient was able to successfully recharge on their own yet, as they planned to retry in a week or two.The logs were not obtained.If the patient is not able to recharge they will contact rep and we will try a different recharger to rule out that as the issue.It was noted the ins is about 1/2 inch deep.Additional information was received from a consumer and a manufacturer representative.It was reported that, the patient was successfully able to recharge their implant now.No further action was going to be taken.However, on 2021-jun-17 the patient (pt) called in to patient services again stating that they received a 1707/coupling issues error.Patient services recommended that the patient lean forward while sitting to optimize ins position, and using the recharger over a thin layer of clothing.Patient services confirmed that the communicator was off while using the recharger.Patient services review recharging best practices.The pt reported since day of implant they have had trouble connecting to charge the ins on and off.The pt stated they tried to charge over the weekend and since then they were not able to connect to charge ins.The pt's ins was at 40%.Patient services walked the pt through trying to charge ins on the call.The pt stated initially that they were seeing 'device not responding' on handset.Patient services reviewed to use recharging application, not my therapy app when charging.The pt was initially getting recharger not found, when the pt opened the recharging application and stated that the communicator was still powered on.The pt powered off the communicator and confirmed that the recharger connected with recharging application, but reported getting searching and service code 1707 when trying to connect to charge the ins.The pt stated they were not able to feel the implant and stated that they think implant is deep.The pt was sitting while trying to charge on the call but stated they were not able to try crossing their leg.The pt could see the implant incision site when looking in a mirror on the call, but stated they were not able to position the recharger over the incision.The pt was going to call patient services back with someone was there to assist the pt with positioning recharger on the ins to continue t roubleshooting.The issue was not resolved through troubleshooting.Additional information was received from the patient.They reported that the cause of the difficulty maintaining connection was determined, however they did not elaborate the cause.They stated they hadn't been able to recharge since they got it and then they went into hosp.They said they were not able to successfully position the recharger over their incision site, and they were not able to successfully charge the ins.The implant was located in their right rear-end.They noted they had left messages for their managing hcp.Additional information received from the patient stated that they are having the same issues with trying to recharge implant, unable to maintain connection since before october.Reviewed troubleshooting steps: reset palpate area however patient said that that it is hard to feel the implant, said it is deep.Patient positioned over implant and after repositioning, recharger connected but less then a minute later, lost connection.Patient said that ins battery level at 20%.Patient did request assistance from someone in the room however the same telemetry issues were experienced.Even when patient leaned forward.The issue was not resolved during the call.Patient said that she fell end of last year and thinks has fallen since the implant.Patient also said that since october has been peeing a lot.Redirected patient to contact hcp office to schedule appointment to check ins site and report fall and ask if hcp will order some imaging to check site.
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This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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