BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1223766 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03510
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 13, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMAP030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED AS RECEIVED, THE DEVICE WAS FOUND TO HAVE NO COMMUNICATION DUE TO A DEPLETED BATTERY. THE DEVICE WAS TESTED ON THE BENCH AND IN THE AUTOMATED ELECTRICAL TEST SYSTEM WITH A POWER SUPPLY AND A NEW BATTERY. NO ANOMALY WAS OBSERVED. THE DEVICE MET ALL SPECIFICATIONS. ANALYSIS OF THE BATTERY FOUND THAT IT WAS DEPLETED, DUE TO AN INTERNAL SHORT CIRCUIT.

    Description of Event or Problem · 1

    IT WAS RRPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE PATIENT WAS IN SINUS RHYTHM AT A RATE OF 42 BPM. DURING A PREVIOUS INTERROGATION IN 2008, THE BATTERY VOLTAGE WAS 3.0V. THE PATIENT REPORTED FEELING A HIGH VOLTAGE SHOCK ABOUT ONE MONTH LATER. THE DEVICE WAS REPLACED.

    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 Required Intervention