MAUDE Adverse Event Report: ST JUDE MED - NEUROMODULATION CHARGING SYS; SCS CHARGING SYS

Model Number 3701

Device Problems Pocket Stimulation (1463); Device Operates Differently Than Expected (2913)

Patient Problem Shock (2072)

Event Date 07/16/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report: 1627487-2013-13797.

Manufacturer Narrative

This charger model was associated with a field correction.Mfr's evaluation: corrective and preventative action (capa) investigation was performed.Result: pocket heating 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 information 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 SYS
• Type of Device: SCS CHARGING SYS
• Manufacturer (Section D): ST JUDE MED - NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264637
• MDR Report Key: 4059189
• MDR Text Key: 4906839
• Report Number: 1627487-2014-03518
• 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: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2013
• Device Model Number: 3701
• Device Lot Number: 119244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2008
• 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 3245; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 43 YR