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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Urinary Frequency (2275); Confusion/ Disorientation (2553); Weight Changes (2607); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 978b128, lot#: va2a0l9, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4)., ubd: 30-jun-2022, 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 gastrointestinal/ pelvic floor.It was reported that for the last 2-3 months patient has experienced return of urgency and urgency incontinence and frequency, uses a pad.Patient's husband said that he did adjust the setting and it helped a little bit.Patient's husband asked for review of programming guidance.Agent did not ask about the circumstances that led to the reported issue.Reviewed therapy information and general programming guidance.During call, they connected to implant and made a slight adjustment and patient confirmed stimulation sensation is comfortable.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.Additional information received indicated that the patient stated that since losing 30lbs, has noticed that the wire is bubbling out.Patient asked if it is going to come through the skin.Patient did not mention any issue regarding lead site, just that can see it more than before, "bubbling out." the patient was redirected to their healthcare provider to further address the issue.Patient redirected patient to show site to hcp for medical assessment.Patient said has hcp appointment on (b)(6) 2021.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: 13151645
• MDR Text Key: 290108388
• Report Number: 3004209178-2022-00022
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 01/04/2022
• Date Device Manufactured: 04/06/2020
• 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 Age: 68 YR
• Patient Sex: Female