MAUDE Adverse Event Report: ABBOTT MEDICAL BRIO IPG, 16-CHANNEL RECHARGEABLE

Model Number 6788

Device Problem Wireless Communication Problem (3283)

Patient Problem Movement Disorder (4412)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient lost therapy due to ipg being inoperable.As such, surgical intervention took place wherein the ipg was explanted and replaced with a new ipg to address the issue.Reportedly, therapy was confirmed post op.

Manufacturer Narrative

The unique device identifier (udi) is not provided because the manufacture date is before sep 24, 2014.A patient's ipg was inoperable was reported to abbott.As a result, the patient's ipg explanted and replaced.Therapy was restored.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.

• Brand Name: BRIO IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: BRIO IPG
• 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: 17011242
• MDR Text Key: 316030067
• Report Number: 1627487-2023-02541
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 6788
• Device Lot Number: 3768677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2012
• 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