MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI CHARGING SYSTEM; SCS CHARGER

Model Number 3721

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

The investigation for capa (b)(4) associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns.The heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating.Recall number: 1627487-07262012-001-c.This charger model was included in a field correction.(b)(4).

Event Description

Device 2 of 2.Reference mfr report: 1627487-2016-05714.It was reported the patient was experiencing an uncomfortable heating while charging and stopped using and charging her ipg over a year ago.The patient is requesting to have her scs system removed.Reference mfr report 1627487-2013-06844 (burning sensation at ipg site not related to charging).On (b)(6) 2012 st.Jude medical, (b)(4), 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.

• Brand Name: EON MINI CHARGING SYSTEM
• Type of Device: SCS CHARGER
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 6076779
• MDR Text Key: 59077483
• Report Number: 1627487-2016-05739
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2010
• Device Model Number: 3721
• Device Lot Number: 2854473
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 1194 (2), SCS ANCHOR; MODEL 3214, SCS LEAD
• Patient Outcome(s): Other