MAUDE Adverse Event Report: MEDTRONIC INTERSTIM IMPLANT FOR URINARY INCONTINENCE

Device Problem Device Inoperable (1663)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/09/2015

Event Type  Other  

Event Description

I have had an interstim implant for about 8 years.Last year my doctor replaced the battery.A year later it's not working at all.My surgery is scheduled for (b)(6).The doctor is going in to replace the wires and then check it and see if he has to replace the whole thing.I thought the fda should know and maybe you can let me know if other people have had this problem.

• Brand Name: INTERSTIM IMPLANT FOR URINARY INCONTINENCE
• Type of Device: INTERSTIM IMPLANT FOR URINARY INCONTINENCE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5297638
• MDR Text Key: 33700985
• Report Number: MW5058491
• Device Sequence Number: 1
• Product Code: EZW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/10/2015

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 82