BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHEM CRT

    MDR report key: 3920580 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14184
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE PATIENTS CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396805 ANTHEM CRT IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM3112 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR