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); Vibration (1674)

Patient Problems Undesired Nerve Stimulation (1980); Ambulation Difficulties (2544); Paresthesia (4421)

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date is estimated; month and year are valid.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

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 towards the end of the week after having a colonscopy pt noticed sensation they had not noticed prior which felt like the battery was vibrating in their butt cheek, they think the battery is moving and sometimes hits a nerve and sends tingles down their legs , when they get up their legs feel wobbly they use a cane to make sure they are sturdy.Pt said: due to these issues they went to the hospital on saturday and the doctor called manufacturer for assistance to turn therapy off and confirmed to the patient they had successfully turned therapy off.Pt said when they got home they noticed it felt like it was not off, the issues were still happening.Offered to assist pt to use their programmer to check the ins status and after successfully synching with the ins pt confirmed seeing no lightning bolt, therapy was actually off.Reviewed to report this to their managing doctor.Pt said they have been trying and had an appointment yesterday but could not make it and now they have an appointment on april 3.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.The patient's relevant medical history included pt said they did not turn therapy off for their colonoscopy and the doctor who did the colonoscopy said it would be ok.Pt said they did not remove any polyps.

• 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: 19041792
• MDR Text Key: 339381663
• Report Number: 3004209178-2024-08473
• 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: 04/04/2024

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: 11/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/04/2024
• Date Device Manufactured: 05/29/2018
• 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 Age: 69 YR
• Patient Sex: Female