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

Model Number 97800

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Incontinence (1928); Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 10/04/2023

Event Type  malfunction  

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.

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 was in the hospital for something else.The caller was on the call with another patient services agent but there was a technical issue so caller called again and spoke with patient services a second time.Caller called the second time from the patient's hospital room phone because the previous number they gave wasn't working very well in the hospital.Caller did not have the hospital phone number but noted the patient was in room 517.Caller is patient's daughter and reported that since the patient got their implant on (b)(6) 2023 (caller confirmed the previous ins had died due to normal battery depletion,) the therapy had not been helping the patient's symptoms of incontinence.Caller stated the patient was peeing all over themselves and they didn't know if it was working.The caller stated that they'd tried different programs and even worked with a pa or np at the managing health care provider (hcp) office but it was still not helping.They stated they'd tried every program.Caller also stated the patient had fallen sometime after seeing np and had commented to the caller a few times that it felt like something wasn't in the same place since then.Caller could not remember when the fall occurred but stated it had been in the fall of 2023.The caller stated the patient's current program setting was hurting in their bike-seat.The caller switched the patient to a new program while on the call with patient services.Patient services guided the caller in connecting and when the caller was helping the patient maneuver to connect, patient services heard the patient gasp in pain when they were moving.Caller was able to successfully connect.The therapy was on and the caller adjusted the stimulation to where the patient could feel the stimulation comfortably in their bike-seat however the patient also described the stimulation when they sat down, "felt like metal" and that something didn't "feel right." patient further clarified that when sitting down they felt pain from the implanted components and they could feel the implanted components inside of them when sitting down, that it was "something hard and it's pushing against me.It feels like metal." patient stated their whole bike-seat region was also swollen.Patient services reviewed stimulation considerations with the caller as well as considerations for falls and how that impacts the therapy and redirected the patient and caller to follow up with the patient's managing health care provider (hcp) because a fall could have definitely impacted the system and caused the components to shift.The caller was going to have the patient try the current program they were on and monitor the patient's symptoms but also call the patient's managing health care provider (hcp) to set up an appointment to check the implanted system.Caller also talked about how the handset battery was draining quickly.Patient services offered to transfer the caller to healthcare it but the caller declined so patient services reviewed basic considerations for handset battery efficiency which let to the caller turning off the wi-fi.Caller also mentioned they would see "session has timed out" on the handset when they would go to use it on occasion.Patient services reviewed the meaning of the message with the caller and the caller did not encounter this message when patient services walked the patient through connecting.

• 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: 19202001
• MDR Text Key: 341287418
• Report Number: 3004209178-2024-09917
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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
• Date Manufacturer Received: 04/18/2024
• Date Device Manufactured: 07/24/2023
• 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: 92 YR
• Patient Sex: Female