BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 1223465 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03645
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. UPON RECEIPT THE DEVICE WOULD NOT COMMUNICATE. THE DEVICE'S BATTERY WAS FOUND TO BE DEPLETED. NO HIGH CURRENT DRAIN SOURCES WERE FOUND DURING TESTING. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION WAS NOT DETERMINED.

    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 DEVICE HAD REACHED EARLY BATTERY DEPLETION 9 MONTHS POST IMPLANT. THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE PROGRAMMED PARAMETERS THAT WOULD DECREASE THE BATTERY AS SUCH A RAPID RATE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention