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); Patient Device Interaction Problem (4001)

Patient Problems Incontinence (1928); Discomfort (2330); Urinary Incontinence (4572)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for urge incontinence and u urinary/bowel dysfunction.It was reported that they wanted to improve the symptom of having a wet pants at the end after they urinated.Pt said since implant it had not helped their symptoms and they had  tenderness.They thought it was moving around when they sit and it hits the chair.Pt said they called the nurse at the doctor's office who told them to change programs.Pt said they saw the doctor a few days ago and the doctor did not say anything.Pt asked  patient services if they should turn therapy off and then start over on the program they got at implant.Patient services reviewed their role, reviewed therapy optimization information, and recommended keeping a symptom diary to track results.Patient services offered and sent email with quick guide, and other information.They redirected to their doctor.They said the manufacturer representative (rep) said they would be keeping in touch with them but they had never heard anything from the rep after that.

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.

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

Additional information was received, from the patient.They reported, that about 2 weeks ago, they has spoken with the manufacturing representative and discussed how they were having "problems" with their device.When they urinated, it would run down their legs.They reported, that initially it had helped their symptoms, but then it stopped helping.They stated, they weren't educated on how to work with the external devices or programming and stimulation considerations.They stated, they went home and started making changes and it wasn't helping them.And that the rep, had the patient try different programs and told the patient that program 5 was what they should stay on.After having the patient try each program and that the patient should give it 2 weeks and monitor their symptoms.Patient stated, that program 5 helped for like 5 days or so, but then it was back to the urine running down their legs and wetting their pants.And it was almost now at two weeks, since they made the change.Patient wanted to know if they should try a different program.The patient wasn't with their handset at the time of the call, so the patient stated, they thought they would maybe try a new program, because they didn't want to go too high on their ins battery and drain it too quickly.They stated, they would monitor their symptoms and call back if they needed further assistance.The patient reported, that their symptoms appeared now to be worse than they ever were.

• 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: 19098690
• MDR Text Key: 340805915
• Report Number: 3004209178-2024-09033
• 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,Followup
• Report Date: 05/13/2024

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/13/2024
• Date Device Manufactured: 12/11/2023
• 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: 64 YR
• Patient Sex: Male