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); Unintended Collision (1429)

Patient Problems Incontinence (1928); Pain (1994); Malaise (2359); Numbness (2415); Constipation (3274); Swelling/ Edema (4577)

Event Date 03/04/2024

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 last week they slipped and landed on their butt and bounced down a couple of steps.Patient states that ever since then they have had swelling, pain and bowel incontinence.Patient reports that they have not had a bowel movement in 9 days and are sick.Patient said they had to do enemas and take prune juice and miralax.The patient was redirected to their healthcare provider to further address the issue.Patient mentioned that they had abdominal ct scan done 2 months ago.Additional information was received on 2024-apr-04, had a recent fall and was in the er needing an mri of their lumbar spine.Caller states when they fell that the ins shifted in pocket.Patient reporting pain and numbness in the foot which is the reason for the mri.The doctors suspect that may have a pinched nerve causing the pain and foot numbness.Ts assisted with reviewing device components and mri eligibility.Confirmed ins is on, no error messages were present at time of call.Pt stated she has already had a ct scan but that it doesn't tell them information about the nerves.Caller asked about removing the ins to get the mri.Redirected to physicians on that decisions.

• 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: 19060331
• MDR Text Key: 339602429
• Report Number: 3004209178-2024-08647
• 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: 04/08/2024

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: 04/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/08/2024
• Date Device Manufactured: 11/08/2014
• 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: 54 YR
• Patient Sex: Female