MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Urinary Retention (2119); Dysuria (2684)

Event Date 10/01/2020

Event Type  malfunction  

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.It was reported that patient said the patient programmer doesn't work.Caller put new batteries in the patient programmer.The patient is going to therapy.They were having pain issues where they can't sleep on their left side.They had pain up and down that side all the way down to leg.They went to neurologist and they did a cat scan or x-ray and they were saying it was their nerves.Neurologist believes it is probably the stimulator even though patient had arthritis on that side.The doctor suggested taken out the stimulator to do a procedure on lumbar area.Patient's issue has been going on for a year.Also the therapy is not helping their symptoms.Patient was not knowing if they were completely emptying their bladder.The patient just started going to the doctor about it, and they were getting worse and worse.Agent did not ask about the circumstances that led to the reported issue.Had patient put new batteries in the patient programmer and it came on.Tried to have the patient connect the handset to the stimulator both with and without the antenna and the patient got poor communication.Patient mentioned the stimulator moved around a lot.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 18975372
• MDR Text Key: 338574051
• Report Number: 3004209178-2024-07772
• Device Sequence Number: 1
• Product Code: EZW
• 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: 03/25/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2013
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• Date Device Manufactured: 03/14/2012
• 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: 66 YR
• Patient Sex: Female