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

Model Number 3721

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 10/29/2014

Event Type  Injury  

Manufacturer Narrative

This device is associated with a field correction.Corrective and preventive action (capa) investigations 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.Results: component/subassembly failure (select specific code from category d).Results: charger.Conclusion: device problem already known - no evaluation will be performed.

Event Description

This report was originally submitted on 12/02/2014 under mfr report # 1627487-2014-000440.The filing is hereby resubmitted to reflect the appropriate mfr report number.Device 2 of 2.Reference mfr report # 1627487-2014-00439.

• Brand Name: EON MINI CHARGING SYSTEM
• Type of Device: SCS CHARGING SYSTEM
• 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: 5108792
• MDR Text Key: 26935733
• Report Number: 1627487-2014-00440
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 3721
• Device Lot Number: 3433678
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2011
• 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
• Patient Outcome(s): Other