MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Unstable (1667); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor therapy.It was reported that the patient is in quite a bit of pain on the hip where the implant was placed, and runs down hip to middle of leg.The patient has not had pain before from the stimulator.If they bend, the patient is in pain.The pain started about two weeks ago.The patient tried to use the patient programmer (pp) and kept getting a signal.The daughter got on the line and they were seeing is on page 69 it was the synchronize icon.It is not a constant pain it is only when the patient has certain movement such as turning or bending.They think the device moved or something.Asked if the patient had any falls or accidents.They said no, the patient started exercising but said they did that before.Had the daughter try and sync the patient programmer again and got an informational screen that she tried to describe but did not recognize.The daughter tried again and then got the setting program 3 at 1.6 volts and stimulation was on.They tried lowering it.Asked if that was better.The patient didn't know because it doesn't hurt all the time.The doctor is gone out of the office until january 11th and there is no other doctor to see.The daughter said they want to turn the therapy off until the doctor is back.Walked them through how to shut off therapy.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11123771
• MDR Text Key: 225304517
• Report Number: 2182207-2021-00019
• Device Sequence Number: 1
• Product Code: EZW
• 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: 01/06/2021

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 Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/06/2021
• 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: 82 YR