BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1223637 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03581
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    May 12, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMAP030054
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED RELIABILITY LABORATORY TECHNICAN NOT APPLICABLE ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY FAILU RE (EVENT) OBSERVED DURING ANALYSIS. THE DEVICE HAD NO TELEMETRY AND WAS SLIGHTLY SWOLLEN.THE BATTERY VOLTAGE WAS TOO LOW FOR RETENTION OF MEMORY VALUES. THE DEVICE CURRENT WAS NORMAL AFTER TEMPERATURE CYCLING. THE BATTERY WAS ANALYZED BY THE MANUFACTURER AND NO ANOMALY WAS DETECTED. THE BATTERY DEPLETION COULD HAVE BEEN DUE TO NORMAL USE; HOWEVER, THE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-343 NA

    Patients

    Seq Age Sex Outcome Treatment
    1