BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROFILE MD V-186 SERIES TIERED THERAPY DEFIB.

    MDR report key: 521986 · Received April 22, 2004

    Report

    Report Number
    2938836-2004-00258
    Event Type
    Death
    Date Received
    April 22, 2004
    Date of Event
    May 6, 2001
    Report Date
    May 6, 2001
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ST. JUDE MEDICAL THAT THE PT EXPIRED IN 2001 DUE TO RENAL FAILURE. THE DEATH WAS NOT SUDDEN OR DEVICE RELATED. THE ICD WAS RETURNED TO ST. JUDE MEDICAL IN 2003, APPROXIMATELY 3 YEARS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE MD V-186 SERIES TIERED THERAPY DEFIB. IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-186HV3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| O SPO1, THERAPY DATES: NA.