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

Model Number 97810

Device Problems Display or Visual Feedback Problem (1184); Energy Output Problem (1431); Battery Problem (2885)

Patient Problems Incontinence (1928); Device Overstimulation of Tissue (1991)

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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.It was reported that their ins was not being effective.Pt stated they had to start taking their medication again because their symptoms had returned.Pt stated the main issue is that they cannot hold going to the bathroom.Pt mentioned they noticed their stimulation setting had adjusted back to 0.1.Pt changed programs about a month ago.Pt has progressively increased their stim and will continue to do so until they see symptom reduction like they had before.Pt mentioned they will recharge their ins every 8-10 days and a while ago they had waited several days longer to recharge.Pt felt like that battery depleting may have caused the stimulation settings to revert back to 0.1.Reviewed therapy expectations.Reviewed effects of stimulation on ins battery.The patient was advised if the situation concerns them they can go see their healthcare provider to further ad dress the issue.  pt also stated when they increase stimulation settings instead of a fluttering sensation they will feel a jumping in their muscles.Advised pt if the feeling is uncomfortable to decrease stimulation.

• 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: 12857503
• MDR Text Key: 285452000
• Report Number: 3004209178-2021-17453
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2021

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: 12/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 11/22/2021
• Date Device Manufactured: 06/24/2021
• 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: 60 YR
• Patient Sex: Female