BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS DR

    MDR report key: 4021793 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14552
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    June 3, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF THE INABILITY TO COMMUNICATE WITH THE DEVICE WAS NOT CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE DEVICE WAS FOUND IN BACKUP VVI AND WAS DUE TO A POWER-ON RESET THAT OCCURRED DURING HV DELIVERY. DEVICE TESTING SHOWED NORMAL FUNCTION. IT IS BELIEVED THAT THE BATTERY VOLTAGE DROPPED DURING HV DELIVERY AND THE DEVICE WAS UNABLE TO MAINTAIN COMMUNICATION UNTIL THE BATTERY VOLTAGE RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COLLAPSED WHILE DOING GARDEN WORK AND REQUIRED RESUSCITATION. THE EMERGENCY ROOM PHYSICIAN DIAGNOSED VF AND TERMINATED IT WITH EXTERNAL DEFIBRILLATION. SINCE THE DEVICE COULD NOT BE INTERROGATED, THE PHYSICIAN DID NOT KNOW IF THE DEVICE DELIVERED THERAPY OR NOT. THE LEAD EXHIBITED LOW HIGH VOLTAGE LEAD IMPEDANCE. THE PATIENT HAD BEEN IN ICU AND THE PHYSICIAN SCHEDULED AN UPGRADE PROCEDURE AFTER THE PATIENT AWOKE. A FEW WEEKS LATER, THE LEAD WAS CAPPED AND THE DEVICE WAS EXPLANTED AND REPLACED. THE PACEMAKER DEPENDENT PATIENT WAS STABLE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498755 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4)