BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGSTROM MD SERIES TIERED THERAPY DEFIBRILLATOR

    MDR report key: 321794 · Received March 14, 2001

    Report

    Report Number
    2938836-2001-00050
    Event Type
    Injury
    Date Received
    March 14, 2001
    Date of Event
    April 14, 2000
    Report Date
    April 14, 2000
    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

    DURING FOLLOW-UP IN 2000, EARLY BATTERY DEPLETION WAS SUSPECTED. THE PHYSICIAN ELECTED TO MONITOR THE PT AND EVALUATE MONTHLY FOR POSSIBLE EXPLANT. ST. JUDE MEDICAL LEARNED ON 2/16/2001 THAT THE DEVICE WAS EXPLANTED IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11574 ANGSTROM MD SERIES TIERED THERAPY DEFIBRILLATOR IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-190HV3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other SPO1, THERAPY DATES: NA.