BEUDAMED
    FDA Adverse Event Death Summary report: N

    OCTRODE 8 PERCUTANEOUS LEAD

    MDR report key: 1580972 · Received January 15, 2010

    Report

    Report Number
    1627487-2010-00015
    Event Type
    Death
    Date Received
    January 15, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 11, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 6: (REFER TO MFR'S REPORT NUMBERS 1627487-2010-0014 FOR DEVICE 1, 1627487-2010-0016 FOR DEVICE 3, 1627487-2010-0017 FOR DEVICE 4, 1627487-2010-0018 FOR DEVICE 5, AND 1627487-2010-0019 FOR DEVICE 6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 2852607

    Patients

    Seq Age Sex Outcome Treatment
    1 Death