BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAMITRODE 4 LEAD

    MDR report key: 1566878 · Received December 23, 2009

    Report

    Report Number
    1627487-2009-00198
    Event Type
    Death
    Date Received
    December 23, 2009
    Date of Event
    December 11, 2009
    Report Date
    December 15, 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

    EVAL: -THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: -THE DEVICE HISTORY STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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 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

    IT WAS REPORTED THE PT WAS IMPLANTED WITH AN SCS SYSTEM IN 2009, AND THAT THE LEADS WERE PLACED OCCIPITALLY FOR HEADACHES. THE PT COULD NO LONGER OBTAIN PAIN RELIEF TO ONE SIDE OF THEIR HEAD WITHOUT LEANING THEIR HEAD BACK. THE PHYSICIAN DECIDED TO REPOSITION THE EXISTING LEAD. SEVEN MONTHS LATER, THE SURGICAL PROCEDURE TO REPOSITION THE LEAD WAS PERFORMED. AFTER THE PHYSICIAN LEFT THE OPERATING ROOM, THE ANESTHESIOLOGIST WAS HAVING DIFFICULTY WAKING UP THE PT AND CALLED FOR ASSISTANCE. WHEN THE STAFF STARTED TO INTUBATE THE PT, THE REP LEFT THE O.R. THE REP LATER TALKED TO THE PT IN THE RECOVERY ROOM. PER THE PT, ONCE RELEASED, THEIR MOTHER WAS GOING TO DRIVE THEM, A 4 HOUR DRIVE, FOR A MONDAY APPT. TO DETERMINE WHY THE PT WAS HAVING SEIZURES. REP WAS INFORMED BY PHYSICIAN, WHEN THE MOTHER ARRIVED IN THE EVENING OF THE SAME DAY, THE MOTHER WAS UNABLE TO WAKE THE PT. THE MOTHER TOOK THE PT TO THE HOSPITAL. THE PT DIED AT THE HOSPITAL. AN AUTOPSY WILL BE PERFORMED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 4 LEAD SPINAL CORD STIMULATOR LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3240 2778456

    Patients

    Seq Age Sex Outcome Treatment
    1 Death