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

Model Number 3058

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

Patient Problems Urinary Retention (2119); Urinary Frequency (2275); Hematuria (2558); Insufficient Information (4580)

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 who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the patient reported they were having problems where they've been urinating every hour or two.The patient stated their managing health care provider (hcp) had told them to call medtronic to see if the therapy could help the patient's symptoms.Patient services reviewed therapy expectations as well as external device function and the patient was able to successfully connect to see their settings.The therapy was off.The patient stated the therapy had been working "to some degree," but that they have had it off for a long time now because they had been "doing different things," and the patient didn't need to use it because they hadn't been having the urinary problems.The urinary problems began again, however, and everything was "blocked" so they were prescribed medicine.The patient stated they switched hcps at that point because they weren't pleased with the way their treatment was going and their current hcp had told them they had these issues from radiation "and prostate," that they had a "radiation problem," and that the patient's best bet would be using the interstim therapy.Patient services assisted the patient in turning the therapy back on and increasing the stimulation to where they could feel it comfortably in the bike-seat region.The patient was going to monitor their symptoms now that a change had been made, make an additional adjustment or call back for assistance if needed and reach out to their managing health care provider (hcp) for further concerns about their symptoms.The patient's relevant medical history included the patient had radiation therapy in 2017 and had been taking pills but the patient wound up with "blockage" so they went to the hospital and a catheter was placed.The patient stated they then had a problem with urinating blood and so that was cauterized and the patient had the implant placed.No further complications were reported at this time.

• Brand Name: INTERSTIM II
• 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: 15391869
• MDR Text Key: 299578095
• Report Number: 3004209178-2022-11575
• 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: 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: 09/09/2022

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: 12/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/09/2022
• Date Device Manufactured: 06/26/2020
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male