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

Model Number 6721

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr report: 1627487-2017-08062.It was reported that the patient ((b)(6)) experienced heating while charging.As a result, surgical intervention may be pending to address this issue.On 8/1/2012 st.Jude medical, neuromodulation division, 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.

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.

Event Description

Device 2 of 2, reference mfr report: 1627487-2017-08062.Follow up revealed that issue has been resolved by replacing the patient's charger.

• Brand Name: BRIO CHARGER 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: 7084484
• MDR Text Key: 93772211
• Report Number: 1627487-2017-08063
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 6721
• Device Lot Number: 4200492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2013
• 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
• Patient Outcome(s): Other