BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADENCE V-110 SERIES TIERED THERAPY DEFIBRILLATOR

    MDR report key: 206382 · Received January 14, 1999

    Report

    Report Number
    2938836-1999-00014
    Event Type
    Death
    Date Received
    January 14, 1999
    Date of Event
    October 16, 1996
    Report Date
    October 16, 1996
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS A RESULT OF THE PRODUCT NOTIFICATION EFFORT UNDER RECALL Z-232-7, ST JUDE MEDICAL LEARNED THAT THIS PERSON HAD DIED. NO DETAILS REGARDING CAUSE OF DEATH WERE ATTAINABLE FROM THE PHYSICIANS. ST JUDE SUBSEQUENTLY REQUESTED AND RECEIVED A DEATH CERTIFICATE. THE CERTIFICATE LISTS CARDIAC ARREST AS THE IMMEDIATE CAUSE OF DEATH WITH ATHEROSCLEROSIS CORONARY ARTERY DISEASE AS A CONDITION LEADING TO THE CARDIAC ARREST. THIS PT DIED AS AN OUTPATIENT IN THE ER AND THERE HAS BEEN NO REPORT FROM THE USER FACILITY THAT THE DEVICE HAD FAILED TO CONVERT AN ARRHYTHMIA. CO IS, HOWEVER, REPORTING THE DEATH BECAUSE CO HAS NEITHER THE DEVICE NOR ANY ASSOCIATED DATA OR ELECTROGRAMS WHICH WOULD ENABLE CO TO CONCLUDE THAT THE DEVICE DID NOT CONTRIBUTE TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADENCE V-110 SERIES TIERED THERAPY DEFIBRILLATOR Implant IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-110C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death 2) CPI BT10,| 3) OSCOR RX-100-TBB.| 1) CPI L67,