BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1895836 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04754
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 23, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED INAPPROPRIATE THERAPY WAS VERIFIED VIA STORED EGMS. THE DEVICE DELIVERED HV SHOCK THERAPY DUE TO NOISE ON THE V-SENSE EGM INPUT. THE RING SETSCREW OF THE DEVICE HAD SEPTUM DEBRIS IN IT WHICH PREVENTED CORRECT INSERTION OF THE SCREW DRIVER TIP INTO THE SCREW CAVITY. THE DEVICE WAS TESTED IN THE AUTOMATED TEST EQUIPMENT SYSTEM AND NO ANOMALIES WERE DETECTED. THE DEVICE MET ALL SPECIFICATIONS. THE CAUSE OF THE NOISE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. THE PHYSICIAN DECIDED TO REPLACE THE LEAD. DURING THE ATTEMPTED LEAD REVISION, THE PHYSICIAN WAS UNABLE TO CONNECT THE LEAD AND BELIEVES THE INAPPROPRIATE SHOCKS WERE THE RESULT OF A CONNECTOR PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7020/65, (B)(4)