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

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Retention (2119)

Event Date 10/01/2023

Event Type  Injury  

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that caller said the doctor had done a botox procedure in (b)(6) 2023 but could only do half of the botox that they had planned due to patient was so rigid.Caller said after 3-4 days patient could no longer pee and went to the hospital where they put in a catheter.Caller said patient had a catheter which was very painful for them until they finally put in a latex free catheter and patient had a catheter until january 4th, when they could pee and now they have a little more control.Caller said while patient had the catheter pain the doctor gave them some lidocaine cream that only relieved the pain for an hour but patient could finally sleep when caller applied a lidocaine pat ch to their end of their penis.Caller also said another new issue of bowel control issues occurred, starting happening after patient had the botox in october.Offered and sent listings to caller's email.Redirect to doctor.The patient's relevant medical history included caller said patient sprays when they pee they hardly get a stream they spray, they think the patient needs to be "reamed out" and caller made a tall garbage can into a urinal.Caller also said pt is legally blind.Caller said they tried to find physician locator on the website but they were not successful.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.B3: date is approximate.Year is confirmed valid.B3: event date is not known.Please see b5 for approximate date range, if applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.They reported that they experienced urinary retention prior to device.The retention got worse after had a procedure hcp did on (b)(6) 2023 and can't control bowel now though could before.The catheterization was not standard of care prior to device.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19012013
• MDR Text Key: 339021123
• Report Number: 3004209178-2024-08198
• 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: Other
• Type of Report: Initial
• Report Date: 04/01/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/01/2024
• Date Device Manufactured: 06/24/2021
• 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 Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 95 KG