BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2151733 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06347
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT ALLEGED RECEIVING MULTIPLE EXTENDED SHOCK THERAPIES DELIVERED OVER A THREE-DAY PERIOD AND HAVING BEEN TREATED FOR A HEART ATTACK. THE PATIENT SUBSEQUENTLY REPORTED THAT HE PRESENTED TO A HOSPITAL AND WAS TREATED FOR A HEART ATTACK, BUT STATED HE WASN'T HAVING A HEART ATTACK, AND THAT HE WAS THEN SENT TO ANOTHER HOSPITAL AND RECEIVED REPEATED SHOCKS FOR NEARLY 100 MINUTES. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS CONTACTED, BUT UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. REVIEW OF THE ARRHYTHMIA LOGBOOK FROM SUBSEQUENT DEVICE DATA UPLOADS SHOWED NO EPISODES WITH SHOCK DELIVERY ON THOSE DATES OR IN RECENT MONTHS, AND NO EVIDENCE OF DATA CORRUPTION OR DEVICE/LEAD ANOMALIES. THE PATIENT LATER ALLEGED THAT HE HAS A MEDICAL REPORT FROM A PHYSICIAN INDICATING A DEVICE MALFUNCTION, BUT DID NOT SPECIFY WHAT THE MALFUNCTION WAS OR WHO THE PHYSICIAN IS. DATA FROM THE DEVICE CONTINUES TO SHOW NO EPISODES OF DELIVERED SHOCK THERAPY OR DEVICE/LEAD ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0185| 4470| T167