MAUDE Adverse Event Report: MEDTRONIC, INC. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3889-28

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/10/2018

Event Type  malfunction  

Event Description

Interstim neurostimulator stopped working.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC, INC.; 7000 central ave. ne; minneapolis MN 55432
• MDR Report Key: 7221126
• MDR Text Key: 98312673
• Report Number: 7221126
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018

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: No Information
• Device Expiration Date: 04/19/2021
• Device Model Number: 3889-28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 92