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); Migration or Expulsion of Device (1395); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Incontinence (1928); Urinary Retention (2119); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Date of event: no information.Concomitant medical products: product id: 3889-28, lot# va105ng, implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: lead.Product id: 3889-28, serial/lot #: (b)(4), ubd: 01-oct-2019, udi#: (b)(4).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 first stimulator.They said their body shut it down.By this they meant that it just completely stopped working.There was something wrong with it.The reading on it would show that everything was fine, and then the healthcare professional (hcp) would 'get in there' and the whole device was bad. the patient said there was some kind of miscommunication or something was not reading right. the patient reported that the hcp said, some leads moved and the leads were bad.The hcp did not know what the issue was and discarded the device.  the impedance showed it was off.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.  (b)(6) 2020 (b)(4) (con): no new information.See pe (b)(4) [see (b)(4) for burning sensation while recharging & (b)(4) for similar issues w/ 2nd 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: 11165401
• MDR Text Key: 226773714
• Report Number: 3004209178-2021-00704
• 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: 03/28/2017
• 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: 10/08/2015
• 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