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); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 01/27/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that their device unexpectedly shutdown on them probably like (b)(6) 2024, they don't know why because they were very good about regularly recharging.Patient (pt) said they called the other day and someone helped them get started successfully charging and said to use the communicator/handset to turn therapy back on once they were charged but those needed to be recharged too, so now their equipment was all charged and pt requested assistance to use the equipment to turn therapy back on.Upon synching with their ins pt said they saw the message: por has occurred.They dismissed the message and when trying to slide the arrow to the word on said nothing was happening.They tapped the up arrow once and made sounds as though stim was suddenly much too high and turned therapy off again.Pt tried again to slide the arrow to on and was successful, amplitude was 0.1 and pt gradually increased confirming they noticed sensation in the bottom of their spine on program 4.Pt said they have always used program 4, they were never on another program since getting the stimulator.Pt decreased the amplitude until they confirmed they no longer felt any sensation.Patient services recommended pt contact their doctor and let the doctor know about the rapy being unexpectedly off when they regularly recharged, stim suddenly too high when they tapped the up arrow, and feeling sensation in the bottom of their spine.Pt said they would call their doctor.Patient called back and stated they had been having some pain and were trying to make an adjustment, but patient stated they figured it out.Patient was able to adjust stimulation on their own.Reviewed external equipment general use.

Manufacturer Narrative

B3: date is approximate.Year is 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
• 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: 19033673
• MDR Text Key: 339291873
• Report Number: 3004209178-2024-08377
• 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: P970004
• 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: 04/03/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/03/2024
• Date Device Manufactured: 03/25/2020
• 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: 81 YR
• Patient Sex: Female