BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 3211417 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09514
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, 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 THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTS PASSING OUT AT HOME. THE PATIENT WANTED TO KNOW WHAT THE DEVICE MONITORING INTERROGATION SHOWED DURING THE REPORTED EPISODE. THE PATIENT WAS REFERRED TO THEIR CLINIC FOR FURTHER INFORMATION. THE FIELD REPRESENTATIVE IS AWARE OF THE SITUATION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308679 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R T180| 0185| 4470