MAUDE Adverse Event Report: MEDTRONIC INTERSTIM BLADDER IMPLANT

Model Number 3058

Device Problems Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574); Defective Component (2292)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 07/01/2016

Event Type  Injury  

Event Description

I have a medtronic interstim implant for my bladder.Around (b)(6) 2016, it started shocking me from my lower left back (where the battery/transmitter is) all the way down my left leg.I had to immediately get my transmitter and turn it off.I had to replace the batteries in my transmitter before it would work, which i had to do every other month.Medtronic sent me a new transmitter to replace that.It was a very painful shock, and after the transmitter was replaced, i tried to cut it back on and was still getting shocked.My doctor made me an appointment on the (b)(6), tests were ran and it was determined to be defective.I have surgery to remove and replace my interstim leads and battery on (b)(6) 2016.

• Brand Name: INTERSTIM BLADDER IMPLANT
• Type of Device: INTERSTIM BLADDER IMPLANT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5842949
• MDR Text Key: 51153663
• Report Number: MW5063796
• 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: 07/29/2016

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: Lay User/Patient
• Device Model Number: 3058
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 59