BEUDAMED
    FDA Adverse Event Death Summary report: N

    OCTRODE PERCUTANEOUS TRIAL LEADS

    MDR report key: 1478086 · Received September 18, 2009

    Report

    Report Number
    1627487-2009-00035
    Event Type
    Death
    Date Received
    September 18, 2009
    Date of Event
    September 13, 2009
    Report Date
    September 14, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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 DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ANS WAS ADVISED ON 9/14/09, THAT THE PATIENT WAS IMPLANTED WITH A PERCUTANEOUS TRIAL LEAD AT T7-T8 FOR LOW BACK AND BILATERAL LEG PAIN THREE DAYS PRIOR. IT WAS REPORTED THAT THE IMPLANT PROCEDURE WAS UNEVENTFUL, STIMULATION WAS TURNED ON POSTOPERATIVE, AND THE PATIENT RETURNED HOME THE SAME DAY AS THE PROCEDURE. LATER THAT DAY, THE PATIENT CALLED THE REP AND STATED THE TRIAL PROGRAMMER DISPLAYED A MESSAGE OF "OPEN CIRCUIT, CHECK CABLES". THE PATIENT WAS INSTRUCTED TO CHANGE TO ANOTHER PRE-ENTERED PROGRAM AND THE ERROR WENT AWAY. THE PATIENT MENTIONED TO THE SALES REP OF A SLIGHT NUMBNESS IN ONE OF THEIR LEGS WHEN ARRIVING HOME FROM THE HOSPITAL. THE PATIENT WAS INSTRUCTED TO CONTACTED THE MD. THE MD STATED THE NUMBNESS WAS LIKELY DUE TO THE CAR RIDE HOME. IT WAS REPORTED LATER THAT DAY THE SYMPTOMS WENT AWAY. THE SALES REP PLACED A FOLLOW-UP CALL TO THE PATIENT THE NEXT DAY. THE SALES REP WAS INFORMED THE PATIENT HAD PASSED AWAY EARLIER THAT MORNING DUE TO AN UNKNOWN CAUSE. THE SALES REP CONTACTED THE IMPLANTING MD WHO WAS UNAWARE OF THE PATIENT'S PASSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS TRIAL LEADS SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3086 2828631

    Patients

    Seq Age Sex Outcome Treatment
    1 Death