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

Model Number	97800
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction.It was reported that the reason for the call was the representative said they were doing a lead revision (see 709415697) and they tested the new lead and 2 of the electrodes came back with high impedance every time.The representative said they put the old battery on and it gave different impedances.The 1 and 2 electrodes were over 4,000 ohms.The representative put the new battery back in and they gave the same value of being high.The representative confirmed they tightened the set screw and tugged on the lead to make sure it was secure.The representative had not tried getting motor response from the lead with the external battery.During the call, the representative was able to get motor response on all 4 electrodes.Electrode 1 & 2 that had high impedances got motor response at 0.4 ma.Technical services (ts) reviewed with caller that the impedance was good, even though it registered high.Ts stated that if impedance was truly high then the patient would not have gotten motor response at 0.4 ma.The issue was not resolved through troubleshooting.Ts left the decision to replace the lead and/or neurostimulator up to the doctor.The rep later reported that all impedances cleared when they changed their position in the operating room and then a second time when impedances were checked again after the surgery closed.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va3b93c); product type: 0200-lead; implant date (b)(6) 2026; 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: 50932642
• Report Number: 3004209178-2026-16503
• Device Sequence Number: 21231951
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: (01)00763000484668(17)241028
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2024
• 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: 09/25/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 66 YR
• Patient Sex: Female