MAUDE Adverse Event Report: ABBOTT MEDICAL BRIO IPG, 16-CHANNEL RECHARGEABLE; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number 6788

Device Problem Premature Discharge of Battery (1057)

Patient Problems Failure of Implant (1924); Movement Disorder (4412)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient¿s ipg was turning off due the ipg charge depleting soon, resulting in increase in recharge burden.Reportedly, patient experienced ineffective therapy as the ipg discharges.As such, surgical intervention may take place at a later date to address the issue.

• Brand Name: BRIO IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: Stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18728204
• MDR Text Key: 335701461
• Report Number: 1627487-2024-07013
• 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
• Type of Report: Initial
• Report Date: 02/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 6788
• Device Lot Number: 5186782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other