BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2780599 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12954
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 17, 2012
    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

    THIS DEVICE WAS DEACTIVATED, AND WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A SHORTED SHOCK LEAD FAULT, LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS AND NOISY SIGNALS ON THE VENTRICULAR CHANNEL. THE NOISE AND OVERSENSING ON THE VENTRICULAR CHANNEL RESULTED IN THE DELIVERY OF INAPPROPRIATE THERAPY. THIS PATIENT WAS IN THE HOSPITAL DUE TO AN UNCONSCIOUS EVENT, BUT THERE WERE NO EPISODES ASSOCIATED WITH THIS ADVERSE EVENT. THE PHYSICIAN DOES NOT FEEL THIS ADVERSE EVENT WAS DUE TO DEVICE MALFUNCTION. THE DECISION WAS MADE TO PROGRAM THE DEVICE TO MONITOR ONLY (MO). THE PHYSICIAN FELT THIS PATIENT WAS NOT WELL ENOUGH TO PERFORM A REVISION PROCEDURE, SO WILL CONTINUE TO EXTERNALLY MONITOR THIS PATIENT AT THE HOSPITAL UNTIL SHE IS WELL ENOUGH TO HAVE SURGERY. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. TECHNICAL SERVICES (TS) RECEIVED A SAVE TO DISK, AND CONFIRMED OUT OF RANGE MEASUREMENTS AND SHORTED SHOCK LEAD FAULT. IT WAS ALSO NOTED THE RIGHT ATRIAL (RA) LEAD IMPEDANCE HAS INCREASED OVER THE PAST YEAR. TS REQUESTED ADDITIONAL INFORMATION. NO FURTHER INFORMATION, HOWEVER, WILL BE PROVIDED AT THIS TIME. THIS PATIENT HAS DEMENTIA, SO NO REVISION PROCEDURE WILL BE PERFORMED. DEVICE TACHY MODE AS BEEN PROGRAMMED TO OFF.

    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 Hospitalization| L| R T167| H195| 0165| 4480