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

Model Number 97810

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431)

Patient Problems Muscular Rigidity (1968); Pain (1994); Insufficient Information (4580)

Event Date 03/25/2024

Event Type  malfunction  

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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy and fecal incontinence.It was reported that their muscles are very tight.Patient is trying to learn how to use this to make it untight.Wanted help turning the amplitude down.Patient said they have been going to the gym and doing therapy.When they go walking their body her muscles don't get tight.The issue started this week.Patient was able to connect to stimulator.The therapy was off.Caller turned the therapy on.Patient was on program 2 at 1.0 volts.Their muscles were tight when turned on.Stimulation was in-between and hurting.Patient turned therapy back off.Wasn't like this before, no soil in underwear no more.In their arms, legs, and in-between muscles hurting bad even when therapy was off.Patient doesn't know what is causing this.Directed patient to call their doctor.

• Brand Name: INTERSTIM
• 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: 19103130
• MDR Text Key: 340811766
• Report Number: 3004209178-2024-09055
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2024

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 Expiration Date: 07/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/14/2024
• Date Device Manufactured: 02/10/2021
• 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: 64 YR
• Patient Sex: Female