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

Model Number 3711

Device Problem Temperature Problem (3022)

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 10/10/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report: 1627487-2014-02784.It was reported the pt experiences heating while charging his ipg.The pt's spouse stated the pt has stopped charging his scs ipg because of welts caused by the heating.The pt's spouse stated the pt did not require any medical attention for the welts.A new replacement charger was sent to the pt 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 the other non-reported events was expected.

Manufacturer Narrative

This charger model was associated with a field correction.Mfr's eval: corrective and preventive action (capa) investigation was performed.Results - pocket heating was confirmed.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.Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: CHARGING SYSTEM
• Type of Device: SCS CHARGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 4249597
• MDR Text Key: 5047717
• Report Number: 1627487-2014-02785
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2014
• Device Model Number: 3711
• Device Lot Number: 4119962
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2014
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2013
• 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
• Treatment: SCS LEAD, MODEL 3186 (X2); SCS ANCHOR: MODEL 1192 (X2); IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 44 YR