MAUDE Adverse Event Report: MEDTRONIC INTERSTIM

Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 12/17/2014

Event Type  Injury  

Event Description

(b)(4).My medtronic interstim caused me nothing but pain when i had it put it.It stopped working after six months of being implanted in me.Serial number (b)(4).Model number 3058.I wish i never had this device implanted in me and would advise consumers not to either.I finally had this device taken out of me in (b)(6) 2017.My doctor had to take it out in pieces as three of the four leads were broken off inside me.What a nightmare this has been for me.I think i now suffer from nerve damage as my right hip and leg go numb all the time on me.

• Brand Name: INTERSTIM
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6934848
• MDR Text Key: 88835920
• Report Number: MW5072647
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability