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

Model Number 97800

Device Problems Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Micturition Urgency (1871)

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

Date is approximate.Month and year are confirmed 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/bowel dysfunction and urge incontinence.It was reported that the patient called last week because she had a doctor appointment and thought they were going to do some kind of ultrasound.The doctor told her she must have done something.Patient has had a hard time keeping her handset and communicator charged.This morning she went to turn it off and it wasn't on.It has been a week since she charged it.Yesterday she felt more urgency.The representative told her if she charged the communicator to put it on her calendar for the end of month or the beginning of the month.The patient said the brighter the light is on the handset the more battery it uses.At the beginning it did make a difference in the battery life of the device.But now she is not even going a week and she doesn't know what she is doing wrong.She said, she thinks something is wrong.Agent had the patient check the battery of her handset and it said 100%.Agent had her turn on the communicator and the battery light was not illuminated.Explained to her that the battery is fine.She is doing physical therapy for her tendon on a leg.She goes swimming.Sometimes after that she feels more bruised on the side of the interstim device.She feels more of a vibration a little bit.When swimming or stretching she can feel more current.Reviewed with caller positional movement and how it affect the stimulation.Reviewed with caller that if the handset or communicator goes dead it does not cause her to have return of symptoms.

• 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: 19124889
• MDR Text Key: 340800916
• Report Number: 3004209178-2024-09226
• 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: 04/17/2024

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: 04/09/2024
• Initial Date FDA Received: 04/17/2024
• Date Device Manufactured: 12/15/2022
• 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: 68 YR
• Patient Sex: Female