BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUIDANT

    MDR report key: 653871 · Received August 26, 2005

    Report

    Report Number
    MW1036447
    Event Type
    Death
    Date Received
    August 26, 2005
    Date of Event
    June 10, 2004
    Report Date
    August 15, 2005
    Manufacturer
    GUIDANT CORP
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT FINISHED HIS DIALYSIS TREATMENT. ALL OF A SUDDEN HIS HEART GOT OUT OF RHYTHM AND HE PASSED OUT. A DEFIBRILLATOR WAS USED ON HIM TO BRING HIM AROUND. TAKEN TO HOSP FIVE DAYS LATER. GUIDANT DEFIBRILLATOR WAS IMPLANTED ON RIGHT CHEST. HE DIDN'T SEEM TO HAVE ANY SHOCKS ETC. BLOOD PRESSURE AND PULSES. ALWAYS STAYED TOO LOW. NEVER DID GOOD WITH THIS. UNABLE TO DRAW MUCH FLUID OFF BECAUSE OF PRESSURE BEING TOO LOW. LEGS AND STOMACH ALWAYS SWELLED BECAUSE OF FLUID. HAD NO ENERGY AND VERY WEAK. UNABLE TO DO ANYTHING. DRESSING, BATHING ETC. UNABLE TO GET UP FROM CHAIR, COMMODE WITHOUT HELP. EIGHT MONTHS LATER, WENT TO DR AND WAS SENT TO HOSP. THE NEXT DAY HAD DIALYSIS IN HOSP AND RELEASED THE FOLLOWING DAY. GIVEN OXYGEN WHILE IN HOSP. TWO DAYS LATER HAD DIALYSIS TREATMENT AND ALSO 2 DAYS LATER. WHEN THEY CAME HOME FELT LIKE HE NEEDED OXYGEN. DID NOT SLEEP ANY THAT NIGHT. THE NEXT DAY, PT'S FAMILY MEMBER WENT TO HOSP EMERGENCY WHERE HE WAS ADMITTED AND OXYGEN BEGAN AGAIN. TWO DAYS LATER, DIALYSIS TREATMENT IN HOSP. DR TOLD PT'S FAMILY HE HAD TWO OR THREE MONTHS AND SHOULD GO ON HEPARIN. THE NEXT DAY, ATE FAIR BREAKFAST AND SOME LUNCH. WANTED SOME SHERBERT WHICH RPTR GOT FOR HIM. AFTER THAT HE DID NOT EAT ANYTHING ELSE AND BEGAN SLEEPING A LOT AND NOT TALKING. AROUND 7:30 NURSES TOLD RPTR HIS HEART RATE WAS LOW AND HIS PULSE VERY WEAK. THEY HAD BEEN HAVING TROUBLE GETTING HIS PULSE. PASSED AWAY ABOUT 9:40 PM. THERE WAS NO SHOCK OR ANYTHING FROM THE DEFIBRILLATOR TO START HIS HEART RHYTHM AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT DEFIBRILLATOR, AICD LWS GUIDANT CORP 1852 *
    2 GUIDANT DEFIBRILLATOR, LEAD LWS GUIDANT CORP. 0157 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H| S