MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION BRIO; DBS IPG

Model Number 6788

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

It was reported during the pt's ((b)(6)) permanent procedure, the physician experienced difficulty connecting the extension to the ipg header due to the screw being placed deep inside the header.The physician attempted to troubleshoot the issue but was unsuccessful.In turn, the physician removed and replaced the ipg.The procedure was extended by approx one hour.No pt complications were reported as a result of this event.

Manufacturer Narrative

This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: BRIO
• Type of Device: DBS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 4094803
• MDR Text Key: 15324336
• Report Number: 1627487-2014-25607
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/19/2014

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: 03/01/2016
• Device Model Number: 6788
• Device Lot Number: 4523202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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