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

Model Number 97800

Device Problems Electromagnetic Interference (1194); High impedance (1291); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/05/2024

Event Type  malfunction  

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

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurosti mulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that the patient got maximum settings reached at 0.2 ma on all 7 programs.The impedance check showed all electrodes at greater than 4k ohms.The rep said the patient called about this matter 2 weeks ago, but they couldn't meet with the patient until todayon (b)(6) 2024.They didn't have any fall/accident/trauma, other than a ct scan recently.Reviewed possible causes of high impedances.The rep mentioned that patient's therapy had been turned off since the night of implant.Troubleshooting was not required.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider (hcp) to further address the issue.Hcp had patient turn therapy on recently to see if further programming can help patient with their urinary issue.

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 manufacturer representative (rep).It was reported that the patient refused surgery to investigate secure connection with contact electrodes within the header of the implanted device.The cause of the max settings and >4k impedance at each electrode pair remains inconclusive for this reason.When asked the most likely cause the rep reported it was theorized at time of rep call to technical services (ts) that this feedback, regarding max setting and out of range impedance was likely attributed to a disconnect between lead and battery.The patient also denied interest in having device removed.The issue will remain unresolved, absent patient consent for surgical exploration.

• Brand Name: INTERSTIM X
• 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: 19151985
• MDR Text Key: 340717522
• Report Number: 3004209178-2024-09474
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/04/2024
• Supplement Dates FDA Received: 05/22/2024
• Date Device Manufactured: 04/18/2023
• 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: 80 YR
• Patient Sex: Female