MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI

Model Number 3788

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Temperature Problem (3022)

Patient Problems Fall (1848); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 12/27/2012

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-26035.It was reported that soon after implant the patient experienced a burning sensation near the implant site.The ipg would turn on full power and turn itself off and would stimulate the sciatic nerve and cause him to fall to the ground.The patient also experienced an increased recharge burden.The ipg was moved to another location on (b)(6) 2012 but this did not resolve the issues.The patient was explanted.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.An increase in prior non-reported heating while charging events and other non-reported events was expected.

Manufacturer Narrative

This ipg serial number was included in a field advisory and a field correction.Sjm has limited information 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
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3682953
• MDR Text Key: 17158196
• Report Number: 1627487-2014-26034
• 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: 12/31/2013

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: Health Professional
• Device Expiration Date: 04/01/2013
• Device Model Number: 3788
• Device Lot Number: 3359052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Treatment: IMPLANT:; SCS EXTENSION: MODEL 3383
• Patient Outcome(s): Other
• Patient Age: 45 YR