MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION EON MINI; SCS IPG

Model Number 3788

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problems Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 04/02/2012

Event Type  Injury  

Event Description

Device 1 of 3.Ref mfr reports: 1627487-2014-06183 and -06184.It was reported the pt experienced excessive heat while recharging and the device shocks him when he moves a certain way.Pt stopped using the device approx 8-10 months after implant and has not recharged it since.Surgical intervention may be pending to address the issue.On 08/01/2012 st jude medical, neuromodulation division, sent field action letters to pts related to heating while charging and raised awareness of this issue to pts.An increase in prior non-reported heating while charging events and other non-reported events was expected.

Manufacturer Narrative

Field advisory: 1627487-07262012-002-r.This ipg serial number was included in a field advisory and a field correction.Sjm has limited info related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: kimberly goode ; 6901 preston rd.; plano, TX 75024 ; 9723098541
• MDR Report Key: 3949034
• MDR Text Key: 4646105
• Report Number: 1627487-2014-06182
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2013
• Device Model Number: 3788
• Device Lot Number: 3404959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR