BEUDAMED
    FDA Adverse Event Injury Summary report: N

    60 CM DUAL EXTENSION

    MDR report key: 1220472 · Received November 4, 2008

    Report

    Report Number
    1627487-2008-00037
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. EXTENSION WAS RETURNED INCOMPLETE AND COULD NOT BE FUNCTIONALLY TESTED. RESULTS - ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. NO FUNCTIONAL TESTING WAS PERFORMED ON INCOMPLETE EXTENSION. VISUAL EXAMINATION FOUND SLIGHT DISCOLORATION ON EXTENSION HEADER AND EXTENSION LEAD SEGMENT BUT NO OTHER ANOMALIES. ANS, INC. 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. ANS, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 4 OF 5 (REFER TO MANUFACTURER'S REPORT NUMBERS 1627487-2008-00034 FOR DEVICE 1, 1627487-2008-00035 FOR DEVICE 2, 1627487-2008-00036 FOR DEVICE 3, AND 1627487-2008-00038 FOR DEVICE 5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60 CM DUAL EXTENSION SPINAL CORD STIMULATOR SURGICAL LEAD GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3346 118778

    Patients

    Seq Age Sex Outcome Treatment
    1 Other