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

Model Number 97800

Device Problem Energy Output Problem (1431)

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Constipation (3274)

Event Date 03/13/2024

Event Type  malfunction  

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the patient had their previous system replaced, the patient had done fine that whole weekend and that week after but had a little bit of pain that wasn't normal on the outside of their hip and caller could not remember the exact morning but the patient woke up and the incision had opened back up and the patient was bleeding.Caller stated they put gauze on it and taped it up and took the patient to the patient's managing health care provider (hcp) on wednesday morning (2024-mar-20) and the hcp told the caller they should have left it open and not put gauze on the site and then poured iodine on the incision site.Caller stated they said it was "fine" but they didn't check it or look at it or anything and sent the patient home.The caller stated the patient was really constipated on wednesday almost to the point of impaction and had a "really heavy feeling," but the patient was finally able to use the bathroom and the heaviness sensation went away.Caller stated they didn't know if it was because of the patient being so constipated or not which didn't allow the patient to feel the stimulation, but after they went to the bathroom and was no longer constipated, they felt the stimulation differently than they had before and the last two mornings the patient has woken up soaking wet, dripping out of their pull ups.Caller stated patient had to change in the bathtub to take the pull up off.The caller was concerned that something was up with the implanted system but said the hcp treated them like they were crazy.The caller also stated in the beginning when the patient got the replacement, they were told by the manufacturer representative not to touch the settings or make any changes.Patient services redirected the caller to follow up with the patient's hcp about their concerns.Caller stated the hcp office told them they/the office didn't do anything with the device/didn't know about the device.Patient services reviewed the hcp could page a manufacturer representative to come to the office to meet with the caller and patient to check the implanted system or to make a therapy setting change.Caller stated they would reach out to the hcp.Documented reported event.No further action was taken by patient services.The patient's relevant medical history included the caller stated the patient was "starting a little bit of dementia" and couldn't really communicate at times what they were feeling.

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 X
• 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: 18996967
• MDR Text Key: 339159467
• Report Number: 3004209178-2024-08000
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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: 03/28/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 03/28/2024
• Date Device Manufactured: 09/21/2023
• 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: 81 YR
• Patient Sex: Female