BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3822954 · Received February 19, 2014

    Report

    Report Number
    1627487-2014-10048
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    December 12, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE. THE OBSERVATION OF HIGH IMPEDANCES WAS CONFIRMED. VISUAL AND ELECTRICAL ANALYSIS OF THE 2 EXTENSIONS CONFIRMED TWO HAD BEEN DAMAGED DURING THE PROCEDURE. ONE OF THE 3 EXTENSIONS HAD BROKEN WIRES WITHIN THE EXTENSION HEADER ASSEMBLY WHICH WAS CONSISTENT WITH STRESS THE EXTENSION WAS SUBJECTED TO DURING THE TIME IT HAD BEEN IMPLANTED IN THE PATIENT. 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 3 OF 3. REFERENCE MFR REPORTS: 1627487-2014-10002, 1627487-2014-10047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103843 UNK DBS LEAD EXTENSION LGW ST JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IMPLANT DATE:| DBS LEAD: MODEL 6149