BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIO

    MDR report key: 2792092 · Received October 11, 2012

    Report

    Report Number
    1627487-2012-10568
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE. SJM HAS LIMITED INFORMATION 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.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-10569. THE PT (B)(6) RECEIVED A DBS SYSTEM WHICH INCLUDED THE IPG AND TWO LEADS (DEVICE INFORMATION FOR THE LEADS WAS REQUESTED; HOWEVER, THAT INFORMATION IS UNAVAILABLE AT THIS TIME). IT WAS REPORTED WHEN STIMULATION WAS INITIALLY TURNED ON, PROGRAMMING WAS NOT POSSIBLE DUE TO IMPEDANCE. THE PT IS CURRENTLY WITHOUT STIMULATION. AN X-RAY HAS BEEN ORDERED IN AN ATTEMPT TO DIAGNOSE THE CAUSE OF THE IMPEDANCE. IT WAS REPORTED THAT A CONNECTION ISSUE IS SUSPECTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIO DBS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 6788 3763181

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention