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 Problem Urinary Tract Infection (2120)

Event Date 02/02/2024

Event Type  Injury  

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 they had to turn their therapy off for almost two months because they had a really bad bladder infection through their body.The patient stated that their managing health care provider had told them to stop using the therapy and in the meantime with the therapy off, their bladder incontinence got really bad.Their health care provider (hcp) recently did a test on their bladder function and the patient stated the doctor told them it was really bad.Their health care provider told them to turn the therapy back on and the patient called for assistance in doing so.Patient services walked the patient through connecting to their settings and the patient was able to successfully turn the stimulation back on and increased to where the patient felt the stimulation comfortably in their bike-seat region.The patient was going to monitor their symptoms now that a change had been made, make an additional adjustment or call back for assistance if needed and reach out to their healthcare provider for further concerns about their symptoms.The patient reported additional medical information: that they had a bladder sling put in and that it eroded inside of them so they had to go back to kaiser about 3 weeks ago to have the pieces taken out of them and that they were a "real mess".Documented reported event.No further actions were taken by patient services.

Manufacturer Narrative

B3.Date is estimated; year is 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.

• 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: 19175581
• MDR Text Key: 340960144
• Report Number: 3004209178-2024-09682
• 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: 04/24/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/24/2024
• Date Device Manufactured: 08/14/2023
• 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 Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female