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

Model Number	97800
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Codes	Discomfort (2330); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction.It was reported that the patient reported stimulation in an unexpected area.The patient stated that about a week ago, when they turned their therapy back on after surgery, they felt the stimulation mostly on their tailbone.The patient stated that they did not change the program; however, they noticed that the pocket where the ins was implanted never used to bother them, and now when they were lying on their left side, it was quite uncomfortable.The agent did not ask about the circumstances that led to the reported issue.The agent reviewed considerations for therapy optimization, general programming guidance, and general use of external devices.The agent walked the patient through connecting to the ins.The patient elected to increase the amplitude.They were able to connect to the ins and increase the stimulation.During the call, the patient felt the stimulation on their tailbone instead of their bicycle seat area.The patient was redirected to their doctor if the issue persisted.
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed 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: 50935167
• Report Number: 3004209178-2026-16538
• Device Sequence Number: 10749756
• Product Code: EZW
• UDI-Device Identifier: 00763000892067
• UDI-Public: (01)00763000892067(17)261228(20)01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 07/08/2025
• 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: 71 YR
• Patient Sex: Female