BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 512935 · Received February 7, 2004

    Report

    Report Number
    MW1031135
    Event Type
    Injury
    Date Received
    February 7, 2004
    Date of Event
    November 14, 2003
    Report Date
    February 7, 2004
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2003, PT ENTERED A HOSPITAL TO HAVE THEIR ICD TESTED AFTER INITIAL IMPLANT IN 2003. IN ORDER TO TEST FOR VF AND/OR VT, THEY PLACE PT UNDER FOR A SHORT PERIOD OF TIME TO CHECK DEVICE WHICH WILL RENDER A SHOCK AND BRING HEART BACK INTO NORMAL BEATS. THE DEVICE RENDERED A SHOCK BUT THE LEADS DID NOT TAKE IT TO THEIR HEART SO PT WENT INTO CARDIAC ARREST. THE COLD PADS OR PATCHES PLACED ON THEIR CHEST DID NOT DELIVER THE NECESSARY SHOCKS TO GET THEIR HEART BACK SO THEY USED A DEFIBRILLATOR TO REVIVE THEM. THIS DEFIBRILLATOR WAS NOT PLUGGED IN PRIOR TO TESTING THE UNIT SO IT HAD TO CHARGE FOR APPROX. 5 MINUTES BEFORE THEY USED IT. IN THE MEAN TIME, THEY KEPT PT GOING WITH CPR AND AIRWAY RESUSCITATION. THEY REVIVED PT BUT ONLY AFTER RECEIVING 2ND DEGREE BURNS FROM DEFIB. PADS PLUS COMPRESSION PAIN FROM CPR. PT WENT THROUGH ANGIOPLASTY 4 MONTHS LATER WITH PLACEMENT OF THREE STENTS IN A "BYPASS GRAFT". THEY TOOK OUT OLD UNIT IN 2003 AND TESTED IT THE FOLLOWING DAY AND SENT PT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL I.C.D. LWS ST. JUDE MEDICAL V-199 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R