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

Model Number 6721

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

This charger model was associated with a field correction.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-22238.It was reported that the patient experienced heating at the ipg pocket when charging the ipg and redness at the ipg site.Information indicates that the patient continued to charge the ipg with the same charging system and no further heating was reported.Reportedly, the issue was resolved.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information was received indicating surgical intervention was undertaken wherein the ipg was explanted and replaced to resolve the issue.

• Brand Name: BRIO CHARGER SYSTEM
• Type of Device: BRIO 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10212571
• MDR Text Key: 196960807
• Report Number: 1627487-2020-22237
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 6721
• Device Lot Number: 5230584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/07/26/2012/001-C
• Patient Sequence Number: 1
• Treatment: DBS IPG; DBS IPG