BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY DR HE IS-1/DF-1

    MDR report key: 1180023 · Received September 30, 2008

    Report

    Report Number
    1180023
    Event Type
    Death
    Date Received
    September 30, 2008
    Date of Event
    May 31, 2008
    Report Date
    September 26, 2008
    Manufacturer
    GUIDANT
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MALE RECEIVED AN AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (AICD) IN 2008. PATIENT INFORMATION ABOUT THE AICD IS ATTACHED. ON THE FOLLOWING MONTH, WHILE AT HOME THE PATIENT EXPERIENCED RESPIRATORY DISTRESS. EMERGENCY TRANSPORT (EMS) WAS CALLED TO TRANSPORT THE PATIENT TO THE HOSPITAL. DURING THE TRANSPORT, HE EXPERIENCED "PULSELESS ELECTRICAL ACTIVITY AT ONE POINT AND WAS BRADYCARDIAC AT ONE POINT, AND WITH TACHYCARDIA AT ANOTHER POINT. ACLS PROTOCOL WAS FOLLOWED. "PER THE PATIENT'S DEATH SUMMARY. THE PATIENT WAS INTUBATED AND PLACED ON A VENTILATOR. IT IS THOUGHT HE EXPERIENCED A SIGNIFICANT ANOXIA EVENT IN TRANSPORT TO THE HOSPITAL PER THE PATIENT'S DEATH SUMMARY. WHILE HOSPITALIZED, HE HAD A TRACHEOSTOMY AND A PEG TUBE PLACEMENT. IT IS THOUGHT HE HAD AN MI PER THE DEATH SUMMARY. HE WAS CODED BUT EXPIRED ON THE FOLLOWING MONTH. AN AUTOPSY WAS PERFORMED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DR HE IS-1/DF-1 AICD LWS GUIDANT T180
    2 DEXTRUS IS-1 BI POSITIVE FIX RA/RV 53 CM AICD LWS GUIDANT 4136
    3 RELIANCE G PASSIVE DUAL COIL 65CM AICD LWS GUIDANT 0175
    4 ATTEMPT GUIDANT AICD LWS GUIDANT T165

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L| O| S