BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2053373 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-06227
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WERE REPROGRAMMED AFTER THE PATIENT EXPERIENCED THREE EPISODES OF A SLOW VENTRICULAR TACHYCARDIA (VT) THAT FELL INTO THE EXISTING MONITOR ONLY ZONE. THE PATIENT EXPERIENCED SYNCOPE DURING ONE OF THESE EPISODES AND THEN REQUIRED MEDICAL ATTENTION. IN RESPONSE, THE MONITOR ONLY ZONE SUBSEQUENTLY WAS REPROGRAMMED TO PROVIDE ATP AND SHOCK THERAPIES WITH A RATE CUT-OFF BELOW THE OBSERVED VT RATE. THE PATIENT ALSO EXHIBITED CONTINUED CHRONIC OVERSENSING IN THE BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR CHAMBERS, BUT THE OVERSENSING DID NOT CONTRIBUTE TO OR AFFECT THE VT EPISODES. THE DEVICE HAD PREVIOUSLY BEEN REPROGRAMMED FOR THE OVERSENSING. THE PATIENT CONTINUES TO BE MONITORED BY HIS CARDIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4)| (B)(4)| (B)(4)