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

Model Number	97800
Medical Device Problem Codes	Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the caller reports that the patient has not used the implant because it has not been doing what it was supposed to be doing since within 6 months of being implanted in 2022.They tried turning it up until the point where it hurts and then back it back down.The caller reported that the patient also has alzheimer's, so even if the device was working, they know what the impact would be with the alzheimer's.The patient was scheduled for an mri yesterday, but when they tried to activate mri mode they saw a screen that the implant was too low and needed to be charged and they could not due the mri.Reviewed that the implant is recharge free.The caller noted that the light on the communicator was yellow.Reviewed that it was likely the communicator that needed to be charged.Caller was not with the patient at the time of the call, but will call back to confirm what the screen was.Additional information was received from a friend/family member.The patient representative called back repeating event history.The caller was encountering low ins battery message on the programmer when synching to ins.The agent reviewed the meaning of this message and redirected to the managing healthcare provider (hcp).The patient was in need of an mri and patient service reviewed the option to keep therapy off to help prolong battery longevity.The agent reviewed steps to activate and deactivate mri mode and the caller opted to leave therapy turned off and would follow up with their managing hcp.Additional information was received from a healthcare provider (hcp).They reported that the patient and the husband of the patient had come into the office for an mri in april and the external equipment could not connect to ins.Someone in the office had called patient and technical services (pats) and the agent told them either the ins was too low or the externals were too low on charge and thus, the ins could not be interrogated.The patient's husband then had spoken to someone at pats in july who had the patient connect to ins and then told the patient that the ins was in mri safe mode and it should be good to scan.The husband told caller the ins was "disabled." the husband then told caller that the "remote does not work." the agent understood the patient and the patient's husband were likely confused about the functionality of externals.The agent reviewed mri information with the caller.The agent also provided national answering service (nas) given the caller's request.Additional information was received from the patient.They reported that the cause of being unable to connect to the ins was known.This was due to normal battery depletion of the ins.The patient reported the question they had was "the ins was implanted in 2022.Why does the ins only last 4 years? the battery in the ins we thought would last 10+ years." when asked the clarify the statement, "the ins was disabled," they reported this was an issue with the implanted device.Th e cause of the ins being disabled was determined.The most likely cause was they put it in mri mode.They were leaving the ins implanted and not removing it surgically.The issue was resolved.When asked to clarify, "the remote does not work," they reported they did not understand how to get it disabled until they met with tech.The most likely cause of this issue was the battery life of the ins and lack of understanding the remote process.The ins when fully charged just did not help their wife with incontinence "(would not recommend)." the issue was not yet resolved and not further action would be taken.
Additional Manufacturer Narrative
B3.Date is estimated; year is valid.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.

• Brand Name: InterStim X
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50935485
• Report Number: 3004209178-2026-16541
• Device Sequence Number: 15852476
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: (01)00763000484668(17)231028
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female