BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFILE MD V-186 SERIES TIERED THERAPY DEFIB.

    MDR report key: 383171 · Received March 15, 2002

    Report

    Report Number
    2938836-2002-00116
    Event Type
    Injury
    Date Received
    March 15, 2002
    Date of Event
    November 29, 2001
    Report Date
    November 29, 2001
    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

    ST. JUDE MEDICAL WAS NOTIFIED ON 03/2002 THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION.

    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 44 YR Other THERAPY DATES: NA.