BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM

    MDR report key: 4232355 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19535
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    PMA / PMN Number
    P910077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT, THE PROGRAMMER UNDERWENT FUNCTIONAL TESTING. THE PROGRAMMER WAS POWERED ON TO CHECK FOR ERROR REPORTS OR BOOT-UP ISSUES. NEXT, TWO TEST DEVICES WERE INTERROGATED SEVERAL TIMES AND THRESHOLDS TESTING WAS PERFORMED AND PASSED. ADDITIONALLY, THE TOUCH SCREEN WAS EVALUATED AND THE SCREEN WAS DENTED WHICH MAY HAVE OCCURRED FROM THE STYLUS. IT WAS NOTED THAT THIS MAY CAUSE THE SCREEN TO FREEZE, HOWEVER, DURING ANALYSIS THIS COULD NOT BE PRODUCED. THE SCREEN WAS REPLACED. THE PRINTER CIRCUIT BOARD AND FLOPPY DISK DRIVE WERE REPLACED. THERE WAS EVIDENCE OF ENVIRONMENTAL DAMAGE TO THE PROGRAMMER AND IMPACTED COMPONENTS WERE REPLACED. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DAY AFTER A DEVICE CHANGE-OUT AND AV NODE ABLATION A NURSE CLINICIAN WAS DOING PREDISCHARGE TESTING. REPORTEDLY THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD CAPTURE TESTS WERE DONE WITHOUT ISSUE. HOWEVER, WHILE DOING THE LEFT VENTRICULAR (LV) LEAD CAPTURE THRESHOLD TEST, THE SCREEN FROZE AND THE CLINICIAN WAS UNABLE TO STOP THE TEST. THE CLINICIAN DID NOT NOTICE ANY TELEMETRY LIGHTS, DROP-OUTS, OR DIALOG BOXES. THE END TEST BUTTON WAS PUSHED, AND WHEN THE TEST CONTINUED IT WAS PUSHED AGAIN SEVERAL TIMES. THE PATIENT HAD A SYNCOPAL EVENT WHEN CAPTURE WAS LOST. THE CLINICIAN WAS USING THE WAND ONLY, AND THE MICS ANTENNA WAS NOT CONNECTED. THE PROGRAMMER IS BEING RETURNED, AND THE FIELD REPRESENTATIVE WILL ATTEMPT TO RETRIEVE THE WAND AND RETURN AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715671 ZOOM LWS GUIDANT PUERTO RICO BV 3120

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening