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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Incontinence (1928); Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

Date of event: no information.Concomitant medical products: product id: 3889-28, lot#: va1t85n, implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.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.The patient reported issues with their second stimulator.They said their body shut it down again (like their first).By this they meant that it just completely stopped working.There was something wrong with it.The patient told their healthcare professional (hcp) that it was behaving like their previous simulator and was not working.The patient said they convinced their hcp to go in and they reported that the hcp said 'yes you shut it down again, i don't know how you keep doing that'.Patient services asked the patient what they meant by 'body shut it down' and whether they were indicating that the battery was drained.The patient said that they knew the battery said it was fine, but the battery was 'completely junk' and wasn't there.The patient said that when the hcp scanned the stimulator it would say 79%, but when the hcp went in the battery was completely dead.The patient said there was some kind of miscommunication or something was not reading right.The patient said that a couple of months before the surgery, they got a referral and went to get a second opinion.The doctor they went to for the second opinion didn't implant the devices so they couldn't do anything, but they said that someone needed to figure out what was going on.Patient services  asked how they knew it wasn't working.They said they couldn't get any urine out.They went back to cathing again.They were having complete accidents multiple times, and cathing 6-7 times a day.  [see (b)(4) for burning sensation while recharging & (b)(4) for similar issues w/ 1st device.].

• 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: 11166942
• MDR Text Key: 227013247
• Report Number: 3004209178-2021-00720
• 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: 01/13/2021

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: 12/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/13/2021
• Date Device Manufactured: 07/11/2018
• 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