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

Model Number 3058

Device Problem Environmental Compatibility Problem (2929)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

Date is estimated; month and year are valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient and a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the reason for the call was that after implant, the patient was doing really well, then it did not help their symptoms, so the caller increased stimulation.Then the patient was doing really well again, but then starting probably two to three weeks ago, the patient had noticed pain right behind where the stimulator was located (upper right buttock) which had progressively gotten worse.The morning of the report, the pain was so bad the patient could not sit up or walk, they could not get off (the toilet) and walk fifteen feet to their chair, they were doubled over it hurt so bad.The caller said they already called the patient's urology doctor's office and talked to someone there who helped them reduce stimulation from 3.8 volts on program 3 down to 0.5 volts, and who also suggested they change to program 4 and call the manufacturer.The caller said the patient was on program 3 at 0.5 volts now, and since reducing stimulation, the patient could move ahead, but they were still having a lot of pain.Later they said it was a little bit of pain.It was reviewed pain could be medical in nature, and if making changes like reducing stimulation or turning stim off did not improve the pain, it would be important to report the pain and issues walking, etc., to a medical doctor to resolve them.The caller was worked with to use the control equipment to deactivate program 3 and activate program 4.The patient came on the phone and stated they wanted to try it with stimulation off.It was recommended to leave stimulation off then and let their doctor know the results to help them resolve the pain issues.They were redirected to follow up with their doctor to further address the issue.The patient's relevant medical history included that their prior ins had been replaced because it went dead.The caller asked if using a heating pad would have caused the pain; they said the patient had post-surgical pain after surgery (not alleged related to device/therapy), and once in a while if it bothered them, they used a heating pad.The caller said the surgery took place in one state, and on (b)(6) 2021, they left to go to another state, where they were now.They said the patient had no problem in the car, and had been riding their three-wheel bike prior to the onset of the pain they were calling about today.

• 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: 13158679
• MDR Text Key: 289613637
• Report Number: 3004209178-2022-00084
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• 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: 01/04/2022

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: 01/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 01/04/2022
• Date Device Manufactured: 08/05/2021
• 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: 84 YR
• Patient Sex: Female