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

Model Number 97800

Device Problem Electromagnetic Interference (1194)

Patient Problems Incontinence (1928); Insufficient Information (4580)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.The reason for call was patient said they noticed it was not helping much with their nighttime symptoms about 3 weeks ago.Pt requested assistance to resolve: searching for communicator by removing the cord and requested assistance make a therapy adjustment.Pt was successful to synch with their ins and increase confirming comfortable sensation.Offered and sent email with quick guide, interstim information.Redirected to their hcp.Additional information was received from the patient.Patient called back regarding making therapy adjustments.Agent walked patient through adjusting stimulation and changing program.Patient will maintain stimulation and monitor symptoms.Additional information was received from the patient.Patient called back and repeated information from yesterday's call.Patient said is still experiencing leaking during the night and would like to make another adjustment and requested assistance.With instruction, patient connected to implant and made a slight increase in the setting.Patient to monitor and track night time symptoms.Patient then asked if x-rays could affect symptoms as had an x-ray performed last friday and friday night is when noticed return of symptoms at night.Reviewed compatibility information.When asked, patient said that since their x-ray last friday, received two new medications: prednisone and a muscle relaxer which has been taking since friday evening/saturday.Patient was directed to check with prescribing physician for information about new medications- known side effects/adverse events.

Manufacturer Narrative

Date is estimated; month and year are 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: 19218551
• MDR Text Key: 341566810
• Report Number: 3004209178-2024-10058
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/30/2024
• Date Device Manufactured: 11/11/2022
• 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: 77 YR
• Patient Sex: Female