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

Model Number 97810

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

On (b)(6) 2022 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 patient was having problems with their device (experiencing symptoms) and they were having connectivity problems when charging.The patient stated they hadn't tried to charge in 7-8 days and that they were seeing the ins was still at 90% charged which they didn't think it should have been since it had been so long since they last recharged.The patient stated that when connected, the ins would be at excellent connection and then they'd lose the connection and connect again and the ins would still be at 90%.The patient confirmed when asked that the recharger application showed the therapy was off.Patient services advised the patient if their ins had been entirely depleted the last time they went to charge, their ins would have been off and that they would have needed to turn the therapy back on after they last charged.The patient stated they hadn't gone into the micro mytherapy application after charging their ins previously (which would have been probably on (b)(6) 2022, the day before they left to go on their cruise) but they never confirmed the ins had entirely depleted previously to turn their ins off.They stated that "maybe going through security at the airport on the (b)(6) turned the ins off." either way, they stated, it hadn't been working for their symptoms.The patient continued to attempt to complete charging the ins and received a 1707 service code and cleared it.They continued to attempt to connect to charge and received another service code which they dismissed and did not tell patient services what the code had been when they asked and lastly they received another 1707 service code.The patient confirmed they weren't near any emi source.They stated their ins was tilted in the pocket, but that it had always been that way.The patient was able to connect again to successfully charge the ins back to 100% and the recharger went inactive and the patient saw a not found message.Patient services had the patient switch from charging to the micro mytherapy application and the communicator.The patient received a "please check device battery level.Therapy is off" message upon connecting and then received a device not responding message.Patient services asked the patient if it had been a power on reset (por) message that they had seen and the patient denied seeing a por.The patient continued to receive the device not responding message even after repositioning the communicator multiple times.Patient services had the patient restart the samsung and the communicator and upon restart, the patient was able to connect to their ins and turn the therapy back on.The patient adjusted the stimulation to where they felt it comfortably in the bike-seat region.The troubleshooting steps that were taken on the call resolved the reported issue.The patient just moved to fl so they did not have a current health care provider (hcp) so patient services sent the patient hcp listings.The patient had previ ously spoken with device registration to update their address before speaking with patient services.  on (b)(6) 2024 additional information was received from the patient.They reported that it had been taking them a very long time to connect to the implant to charge the implant and that sometimes they would just give up because it took so long to connect.Patient services asked the patient if they had any falls or traumas that led to the issue and the patient stated "no," that they used to work (and that they retired two years ago) and when they were working they would sit a lot.The twisting was because of the way they would sit at work and so the ins twisting had to have been at least 2 years ago or even more than that.The patient no longer has a managing doctor, so listings were sent to them to address their device issue.[omitted rule out in gen text].

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.They reported that they haven't taken any steps to resolve the issue yet.They plan on contacting a doctor this is their second device to do the same thing.

• 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: 18694852
• MDR Text Key: 335247908
• Report Number: 3004209178-2024-04531
• Device Sequence Number: 1
• Product Code: EZW
• 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: Other
• Type of Report: Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• Date Device Manufactured: 09/26/2020
• 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
• Patient Age: 67 YR
• Patient Sex: Female