BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2922205 · Received January 18, 2013

    Report

    Report Number
    1644487-2013-00187
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    October 19, 2012
    Report Date
    January 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN OCTOBER BY OUR DISTRIBUTOR IN HONG KONG THE FOLLOWING "PATIENT FELT DOWN, LOST CONSCIOUS AND HIT THE WALL PRETTY HARD. AFTER THE LAST SETTING, HE HAS KNOCKED HIS HEAD OFF AND INJURED HIS HEAD BADLY 3 TIMES." THE PATIENT HAS DROP ATTACKS AND NOT REPORTED TO BE A NEW SEIZURE TYPE FOR THE PATIENT. THE PATIENT IS STABLE NOW AND NO MORE DROP ATTACKS. AFTER IMPLANT THE PATIENT HAD A PERIOD OF TWO TO THREE MONTHS WITHOUT DROP ATTACKS. THE PATIENT HAS AROUND A 50% DECREASE IN THEIR SEIZURES WITH THE VNS AT THIS TIME. NO MEDICATION CHANGES WERE MADE PRECEDING THE EVENT. THE DOCTOR IS TRYING TO DECREASE THEIR MEDICATIONS AS THE PATIENT IS CURRENTLY STABLE. THE DROP ATTACKS THE PATIENT WAS HAVING WERE ABOVE BASELINE FOR THE PATIENT. NO FURTHER INTERVENTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED IN REGARDS TO THIS VNS PATIENT. THE PATIENT HAD A VERY GOOD CLINICAL OUTCOME AT THE BEGINNING AFTER IMPLANTED. HIS SEIZURES WERE CONTROLLABLE FOR ABOUT 2-3 MONTHS. AFTER IMPLANTATION ON THE FIRST MONTH, THERE WAS 0-1 SMALL SEIZURE ONLY . THE DOCTOR THEN DECIDED TO INCREASE THE CURRENT SETTING FROM 0.5MA TO 0.75MA AND FINALLY TO 1.00 MA AFTER A FEW MONTHS. HOWEVER, IT HAS CHANGED TOTALLY. HIS CONDITION. HIS SEIZURES ARE WORSE IN TERMS OF FREQUENCY AND QUALITY. HIS SETTINGS WERE LOWERED TO THE RATE THEY WERE AFTER SURGERY. THEIR CONDITION RECENTLY IS JUST ABOUT THE SAME AS IT WAS PREVNS IMPLANTATION. THEIR SEIZURES ARE GTC AND ATONIC SEIZURES, CAUSING SUDDEN FALL AND INJURY TO HIS HEAD REQUIRING MANY STITCHES IN SEVERAL LOCATIONS. THE PATIENT IS BEING MONITORED TO SEE THE OUTCOME OF LOWERING THEIR THERAPY.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION HAS BEEN ATTAINED IN REGARDS TO THE PATIENT'S OUTCOME OF ADJUSTING THEIR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27642 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 20195

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other