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

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.Patient isn't sure if the device is working for them or not because they started having a return of symptoms which has been "horrible".During the call, the patient had access to their patient programmer (pp) so they synched to their ins which showed stimulation was on; they were at 2.3v on program 4.They have the ability to change programs and/or adjust stimulation so stimulation was increased to 2.7v where they reported being comfortable.The patient was instructed to review any directions previously given to them by their healthcare provider (hcp).It was reviewed that it takes time for body to respond to therapy, therefore titrations should be discussed with their hcp.It was also reviewed to consider completing a voiding diary to track progression/therapeutic response.Therapy expectations (50% reduction in symptoms) was also reviewed.It was lastly reviewed to follow up with the hcp if the problem does not resolve; they will monitor their symptoms now that a change was made.Patient noted that if increasing doesn't resolve the issues, they may consider changing programs and might call back for assistance.No device issue was reported and no further patient complications have been reported as a result of this event.Additional information was received from the patient.They reported that it hasn¿t helped and they had worked with a manufacture representative for programming however still hadn¿t helped.The patient wanted the device removed.The patient reported having another planned unrelated surgery and wanted the whole system removed prior to the unrelated surgery.The patient was attempting to get a hold of the healthcare professional office but had not heard back.The patient was redirected to their healthcare professional.The patient relevant medical history included them being diabetic and having an insulin pump.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10837293
• MDR Text Key: 216179540
• Report Number: 3004209178-2020-19961
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/13/2020
• Date Device Manufactured: 10/16/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 37 YR