MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 97810

Device Problems Migration or Expulsion of Device (1395); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that since implant, they couldn't get the recharger to charge the implant.Patient states they tried using a belt but it wouldn't stay in place and tried sitting on it to charge but that didn't resolve the issue.Troubleshooting was unable to be performed as patient states their equipment is lost from their move.Patient states it's there somewhere but not currently with them at the time of the call.Patient inquired about device model and serial number to provide to mri facility as they are in need of an mri.Agent reviewed device info, but also reviewed mri mode would be needed.Patient will provide mri facility with device info and will call back if needed to troubleshoot.Additional information was received from the patient.Patient called back to reiterate they hadn't used their ins since 2021 because it just wasn't working for them and they couldn't get it to charge.Patient reiterated that they had trouble sitting back on the recharger and getting the ins to charge but that now they had a belt that fit.Patient stated they charged the system twice now and that they had to get another programmer because the other programmer stopped working and they were trying to connect to their settings.Patient wanted information on programming to consider and agent reviewed device description/function with the patient and patient wanted to connect to their settings so agent walked the patient through connecting however they got a 'no device found message'.Patient stated they could feel where the ins was and they were over it.Agent asked the caller when the last time was they charged the ins and the caller stated they thought they had charged it up yesterday (2024-mar-19) but the recharger didn't make the noise like it was finished it flashed orange instead so they thought it was done.Agent had the caller turn the communicator off and switch to the recharger application and the caller stated they'd never used the app before.Caller turned on the recharger and received a 'not found' message.Caller switched rechargers but still got a 'not found' message so agent had the caller do a recharger reset but they still got a not found message.Caller did another reset and this time they got a service code which they dismissed and the recharger application showed the recharger went to 'searching' for the ins.Caller placed the recharger over the ins and received an open loop charging screen with a low of 3, then medium of 4 and high of 10.Caller stated numbers were changing between 1-2 and 3.Agent reviewed with the caller to be certain they were not near any metal and to continue to charge until they switched to close loop charging and to call back if they ran into an issue or when they finished charging the ins to continue troubleshooting connecting to settings.Patient stated they needed an mri so that's why they were trying to charge right now and noted they would call back.Patient called back to report that they thought they saw they were able to see the ins get to 60% while charging but then the recharger went inactive and they got a service code.Agent reviewed the meaning of the message and tried to assist the patient in attempting to continue to charge the ins.The patient only had an open loop charging screen.There were initially in their wheelchair so patient was instructed to move away from metal and sat ina chair instead and attempted to charge again however they still got the open loop charging screen.Patient asked if they could just try to connect to their ins settings using the communicator in the therapy application so agent walked the patient through trying to connect only they kept seeing "searching for device" and then it went directly to "no device found" again.Patient state they were 75% sure they saw the ins had charged up to 60% but they weren't 100% sure.Patient stated it was hard to find the ins and that it had moved from where it was before and they were heavy so it made it more di fficult to locate the ins.Patient confirmed when agentasked that they'd had many falls that could have contributed to the ins moving.The patient stated they'd have to cancel their mri appointment.The troubleshooting steps taken on the call did not resolve the reported issue.Agent redirected the patient to follow up with their managing health care provider (hcp) to check the implanted system.The patient stated they would reach out to their hcp.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.When asked they stated that the cause of the issue was not determined and that a manufacturing representative (rep) would be meeting them on (b)(6) 2024 at their hcps office to help troubleshoot.They had done so with their hcp who was now calling in reinforcements.This had not yet been resolved.On 2024-apr-29 the patient called in.The reason for call was patient reported that since implant, they hadn't been able to charge their implant past 10% and were now getting it replaced.Patient stated that they were getting their device replaced on (b)(6) 2024.Patient reported that they saw their hcp for their charging issues, and that a rep was there.Patient stated that the doctor tried to get their device charged for 2 hours.Patient stated the device worked for a couple months, but since then they have tried to charge the device and it has always had issues.Lately, they have really tried extensively since they need an mri.Troubleshooting was not required.The patient also called to inquire how to dispose of their external components, patient stated that they don't know how to, and email was set to repair for product return.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Continuation of d10: product id wr9220 lot# serial# (b)(6) product type recharger.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that since implant, they couldn't get the recharger to charge the implant.Patient states they tried using a additional information was received from the patient.The patient stated that the cause was unknown and that the device would be replaced on (b)(6).

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19034203
• MDR Text Key: 339282779
• Report Number: 3004209178-2024-08382
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/24/2024; 05/10/2024
• Supplement Dates FDA Received: 05/06/2024; 05/15/2024
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female