MAUDE Adverse Event Report: MEDTRONIC STIMULATION SYSTEM

Model Number 33713

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Therapeutic Response, Decreased (2271); Discomfort (2330); Electric Shock (2554)

Event Date 07/01/2014

Event Type  Injury  

Event Description

I had medtronic neurostimulator implanted in my lower right back in (b)(6) 2008.The product worked fine up until last year.At that time the product just stopped working.I was not able to charge the stimulator any longer and from that time forward i have had nothing but problems with the unit.I have received shocks, pain in my back, a feeling of tugging at the unit and the wires and oddly enough a problem with using all types of electronic devices.Exactly what has happened i am not sure.I met with the medtronic rep who tried to charge the unit thinking the battery was dead; however, the unit was not able to be charged.What i am not understanding is it the unit was in fact useless because the battery no longer functioned, then how can i still be feeling these shocks, pain, and pulling feeling.I read on your website that emi can have an effect on an implanted medical device.Can this happen even if the battery in the unit is not operable.What types of emi can effect an implantable device in this way? all the safety info that i had for the unit was unfortunately stolen last year (b)(6) 2013, and i have had an extremely difficult time getting this info from medtronic.Any info that you can provide me i would greatly appreciate.I am having the battery part of the unit removed next week, but i am concerned about the items (wires, paddle) that will remain and if i will still have these problems.

• Brand Name: STIMULATION SYSTEM
• Type of Device: STIMULATION SYSTEM
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4777545
• MDR Text Key: 5779285
• Report Number: MW5042732
• Device Sequence Number: 1
• Product Code: GZB
• 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: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 33713
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 61