BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 3900996 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12647
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED IMPEDANCE MEASUREMENT ANOMALY WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE PROGRAMMER PRINTOUTS. THE DEVICE WAS TESTED ON THE BENCH AND THE HIGH VOLTAGE OUTPUT CIRCUIT WAS NOTED TO BE DAMAGED. AN ARC MARK WAS FOUND ON THE DEVICE CAN. FURTHER EVALUATION OF THE ARC MARK INDICATED THE PRESENCE OF LEAD MATERIAL. THE CAUSE OF THE REPORTED IMPEDANCE ANOMALY WAS A LEAD ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM FOR CARDIAC SURGERY. A MAGNET TO DISABLE HV THERAPY WAS NOT USED AND INSTEAD REPROGRAMMED THE VENTRICULAR SENSING ABOVE NORMAL. ELECTROCAUTERY WAS USED DURING THE PROCEDURE. AT THE FOLLOW-UP THE NEXT DAY THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT CONDITION IS FINE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST MITRAL VALVE SURGERY, THE DEVICE EXHIBITED TWO ALERTS, ONE FOR HIGH HV IMPEDANCE, AND THE OTHER FOR SHOCKS BEING DELIVERED. AN IMPEDANCE MEASUREMENT TEST FAILED. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380901 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention