MAUDE Adverse Event Report: ST JUDE MEDICAL EON MINI IPG

Model Number 3788

Device Problems Leak/Splash (1354); Self-Activation or Keying (1557); Device Stops Intermittently (1599)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Alteration In Body Temperature (2682)

Event Date 11/25/2013

Event Type  Injury  

Event Description

St jude spinal cord stimulator implanted around or about (b)(6) 2012.Functioned properly until (b)(6) 2012 when device was turned off (because i was driving), the device turned itself on at max level.Later that month the rep for st jude disabled the magnetic shut off component of the device.The device had some intermittent episodes where the devices would turn off and then back on but at set level of function, for the next few months this would occur, but not on a daily basis.By late winter of 2013, the episodes became daily, with no pattern of time during the day or position.Contact with st jude medical device reps; reprogramming devices was unsuccessful.Was told by st jude reps that it was the body rejecting the device and the device was not shutting on and off itself.This behavior of the device continued to worsen and became more frequent.Several times throughout the day it would shut itself off and then turn back on.Sometimes it would shut off for a few seconds sometimes several seconds.Then the device start turning itself on without being turned on by the programmer device as in the first episode.St jude recommended the device be removed and tested at their lab in (b)(4).It was surgically removed in fall 2013.The device was given to a st jude rep who sent it to their lab in (b)(4).After several weeks, without a response, contacted the rep and after multiple conversations was told by the local rep that the device tested normal without issues.Requested that the device be sent to me for independent testing, the rep said it could not be sent to us because it was in "hundreds of pieces." i then contacted the corporate office of st jude medical and was told, over the phone, by an administrative assistant the device tested as normal without problems.When asked specifics of test (setting of the device, position of device, length of test) she could not give me any details.After multiple conversations with this individual ((b)(4)).We then requested, again, that the device be sent to us, which it has been.We are in possession of the device and have not opened the sealed bag it is in.The electrical sensation from the device stopped after the battery device was removed, the electrodes are still in place.The device site continues to hurt, burn, swells, gets hot, and is very hypersensitive; concerned about battery leakage in area.St jude has not been very cooperative in giving information concerning this device.Asked for all paperwork concerning this device and conversations with reps, and was told there was no documentation.

• Brand Name: EON MINI IPG
• Type of Device: EON MINI IPG
• Manufacturer (Section D): ST JUDE MEDICAL
• MDR Report Key: 3731848
• MDR Text Key: 4328367
• Report Number: MW5035478
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3788
• Device Lot Number: 3599354
• Other Device ID Number: (1) 05414734402651
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR