BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 1073523 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02417
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 21, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DRAINED EXCESSIVELY BETWEEN DEVICE CHECKS. THERE DID NOT APPEAR TO BE ANY HIGH VOLTAGE THERAPIES DELIVERED BETWEEN CHECKS. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-365 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention