BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS + VR

    MDR report key: 4170178 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02874
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    March 20, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION: THE REPORTED FIELD EVENT OF OUTPUT ANOMALY WAS CONFIRMED IN THE LABORATORY. AN ARC AND POLISH MARK WERE OBSERVED ON THE DEVICE. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND FOUND OUTPUT STAGE TO BE DAMAGED. OUTPUT TRANSISTORS WERE DAMAGED DURING BENCH TESTING. TI IS BELIEVED THE LEAD ARCED TO THE ICD CAN ADN SHORTED THE HIGH VOLTAGE OUTPUT CIRCUITRY WITHIN THE ICD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR PAIN DUE TO RECENT HV THERAPIES. INTERROGATION OF THE DEVICE SHOWED AN ALERT FOR POSSIBLE OUTPUT CIRCUIT DAMAGE AFTER A HIGH VOLTAGE THERAPY DELIVERY. DEVICE REPORTED IT WAS IN RESET. REVIEW OF THE RECENT THERAPIES SHOWED SEVERAL INEFFECTIVE ATTEMPTED HV THERAPIES. OUTPUT CIRCUIT DAMAGE WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23740 ATLAS + VR IMPLANTABLE CARDIOVERTER DEFBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD V-193

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 1581/65, RH37254