BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2920929 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01318
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS SEEN IN THE EMERGENCY ROOM DUE TO MULTIPLE SHOCKS. A FIELD REPRESENTATIVE PERFORMED A DEVICE EVALUATION AND AFTER DISCUSSION WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS), IT WAS SUSPECTED THAT THE SHOCKS WERE INAPPROPRIATE AND DUE TO T-WAVE OVERSENSING; WITH SOME EPISODES THERAPY WAS EXHAUSTED. LEAD IMPEDANCES WERE STABLE AND NO NOISE WAS NOTED ON THE LEAD. THE DEVICE WAS REPROGRAMMED TO MONITOR ONLY, AND THE PLAN WAS TO KEEP LEAVE IT OFF UNTIL THE PATIENT'S ELECTROLYTE AND KIDNEY FUNCTION STABILIZED. HOWEVER, THE PATIENT WAS ADAMANT THAT HE DID NOT WANT IT TURNED BACK ON. ACCORDING TO A PHYSICIANS ASSISTANT AT THE HOSPITAL, THE PATIENT HAS A DO NOT RESUSCITATE (DNR) ORDER AND HAS SURGERY SCHEDULED TO REMOVE THE DEVICE IN THE UPCOMING WEEKS. AT THIS TIME, EVIDENCE SUGGESTS THE DEVICE REMAINS IN SERVICE, BUT PROGRAMMED TO MONITOR ONLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26388 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR T175| 6947| 7275