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

Model Number	97800
Medical Device Problem Codes	Electromagnetic Interference (1194); Electromagnetic Compatibility Problem (2927); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Incontinence (1928); Anxiety (2328)
Date of Event	08/26/2026
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 they had an emg last week and turned therapy off to be on the safe side but when they turned it back on they got the message: the system is operating at maximum settings and their setting was program a, 1.5, they have not tried any other programs.The patient (pt) said their note about program a said, up to 5.0 but pt did not recall what the amplitude had been before they turned it off for the emg and pt said they were not sure if the max settings message appeared when they turned it off or not because they had been very nervous.Reviewed meaning of max settings message and asked pt to synch to their ins and navigate to the battery section, their mybattery showed ok.Pt said they have not had any falls, they had several mris.The pt also reported their symptoms were 50% improved over their baseline but their results were not the same as they were during the evaluation.The pt said they still have to wear the heaviest pads all the time and run to the bathroom.The pt said in the 3 months following the implant procedure they met with manufacturer reps (asked/unk names) several times to try to improve their symptom results.Redirected to report the issue to their doctor.
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: 50927552
• Report Number: 3004209178-2026-16479
• Device Sequence Number: 21514183
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: (01)00763000484668(17)250114
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 01/14/2025
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 07/20/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Female