BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS DR

    MDR report key: 1010609 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01190
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    January 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    Z1506
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE BENCH AND ON THE AUTOMATED ELECTRICAL TEST SYSTEM. NO ANOMALY WAS DETECTED EXCEPT FOR AN EXTENDED CHARGE TIME. THE DEVICE CURRENT DRAIN MEASUREMENTS WERE NORMAL. THE LONGEVITY WAS ESTIMATED USING THE TWO AVAILABLE ARCHIVED SESSIONS AND THE PROGRAMMED PARAMETERS AND DIAGNOSTICS. IT IS BELIEVED THAT THE PREMATURE DEPLETION WAS DUE TO THE BATTERY, ALTHOUGH NOT ALL OF THE ARCHIVED DATA WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A SHAFT BREAK OCCURRED. WHILE THE PHYSICIAN WAS PREPPING THE 3.00X12MM MAVERICK2 BALLOON TO TREAT THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) IT WAS NOTICED THAT THE SHAFT OF THE DEVICE WAS BROKEN. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS 'WELL'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention