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 06/20/2014

Event Type  Injury  

Event Description

Info received identified that pt experienced a burning sensation when sjm reps reprogrammed the device which happened several times over a period of months.After about 15 minutes of charging, the implant site would become extremely hot.It felt like the burning was coming from the inside and her skin was hot to the touch and got pink.Pt gets shocking, needle-like sensations when the implant site is pushed in or when lying down.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

This ipg serial number was included in a field advisory.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
• 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: 3976359
• MDR Text Key: 4631967
• Report Number: 1627487-2014-06199
• 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: Recall
• Type of Report: Initial
• Report Date: 06/20/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2011
• Device Model Number: 3788
• Device Lot Number: 2893854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Treatment: SCS LEAD, MODEL 3166,; IMPLANT DATE:; IMPLANT DATE:; SCS LEAD, MODEL 3245,
• Patient Outcome(s): Other
• Patient Age: 60 YR