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

Model Number 97800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Constipation (3274)

Event Date 10/12/2022

Event Type  Injury  

Event Description

It was reported that the patient received the ins due to retention and said the ins worked well for a while but then they noticed in (b)(6) 2023, they started to have leakage at night.Patient said it started slowly, like a stress incontinence but then "quickly and gradually" the leakage increased.Patient said they discussed it with their healthcare provider (hcp) and tried various settings but eventually the hcp had to replace the lead. the reason for call was since date of implant the patient is still experiencing incontinence at night and they can't fall asleep until 4:00 in the morning so they can use the bathroom one more time.Patient said they've increased stimulation today and could feel a tingling in the perinium and they can almost feel it in their foot.Reviewed general therapy guidelines, programming considerations, therapy optimization and therapy relief vs stim sensation.Patient said they will decrease stim, continue to monitor symptoms and will follow up with the hcp at their appt next week.Caller called back and noted that they frequently get overactive bladder at night.They had this issue previously as well, but then they replaced the lead.Reviewed intensities and programs with the caller.The caller noted that they are on anti-depressants and sleep medication/sedatives and wanted to know if that can impact therapy.Reviewed that we know diet and medication can have an impact, but to speak to hcp or pharmacist about that.The caller also noted that they have experienced constipation recently and have been trying to change their diet and are taking fiber gummies.Reviewed potential impact of therapy.

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.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: 18953891
• MDR Text Key: 338305905
• Report Number: 3004209178-2024-07560
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

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: 02/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 03/21/2024
• Date Device Manufactured: 08/29/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female