BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 3220084 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04675
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 9, 2013
    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
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER UPON RECEIPT AND WAS FOUND TO BE DUE TO LOW BATTERY VOLTAGE. WITH AN EXTERNAL POWER SUPPLY, THE DEVICE FUNCTIONED NORMALLY; NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW-UP, THE DEVICE COULD NOT BE INTERROGATED WITH TWO SEPARATE PROGRAMMERS. AN INTERROGATION ATTEMPT IN ANOTHER ROOM WAS UNSUCCESSFUL. THE PATIENT DID NOT REPORT RECEIVING ANY SHOCKS. THE PATIENT HAD TRAVELLED ABROAD AND REPORTED WALKING BY A LARGE POWER SOURCE. ALL DEVICE PARAMETERS WERE NORMAL AT THE LAST CHECK. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320351 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention