BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIO

    MDR report key: 4093613 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-25593
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2014-25594. THE PATIENT HAS TWO DBS EXTENSIONS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT (B)(6) LOST STIMULATION. DIAGNOSTIC TESTING REVEALED IMPEDANCE ISSUES. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADDRESS THE ISSUE. DURING THE PROCEDURE, INTRAOPERATIVE TESTING AND TROUBLESHOOTING IDENTIFIED HIGH IMPEDANCE MEASUREMENTS ON BOTH EXTENSIONS. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED THE EXTENSIONS AND IPG. EFFECTIVE STIMULATION WAS RESTORED POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541584 BRIO DBS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 6788 3450542

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DBS LEAD, MODEL: 6149| DBS LEAD, MODEL: 6147| IMPLANT DATE:| IMPLANT DATE: