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

Model Number 3788

Device Problem Temperature Problem (3022)

Patient Problems Shock (2072); Burning Sensation (2146)

Event Date 01/07/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report# 1627487-2014-01617.It was reported the pt experienced pocket heating while recharging and a sporadic shocking sensation at various times.Subsequently, the scs system was explanted due to an unspecified reason.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 correction.Eval results: there was no complaint associated with this issue.The system was returned for unspecified reasons.Visually inspection of the ipg revealed no anomaly or damage.As received, the returned ipg did not communicate with lab utility devices due to battery depletion.The pt stopped using the system for sometime.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 MED - NEUROMODULATION; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 4117346
• MDR Text Key: 4925298
• Report Number: 1627487-2014-01616
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2013
• Device Model Number: 3788
• Device Lot Number: 3527446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS LEAD: MODEL 3186 (2); IMPLANT DATE:; SCS ANCHOR: MODEL 1192 (2)
• Patient Outcome(s): Other
• Patient Age: 61 YR