BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3212519 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08879
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 31, 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
    PHYSICIAN

    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 WITH THIS LEAD REPORTED FEELING UNWELL AND WAS ADMITTED TO THE HOSPITAL, AND WAS HOOKED UP TO AN EXTERNAL HOLTER MONITOR. A LOSS OF CAPTURE (LOC) OCCURED IN THE VENTRICLE UP TO 4 SECONDS. ALL OTHER LEAD MEASUREMENTS WERE CONFIRMED NORMAL AND WITH IN RANGE. THE DEVICE WAS INTERROGATED AND NO OVERSENSING OR BREAKS IN ARRYTHMIAS. AFTER FURTHER REVIEW WITH THE PATIENT THE PHYSICIAN DISCOVERED THAT THE PATIENT HAD A VIOLENT FALL ON THEIR CHEST 2 MONTHS PRIOR AND A SHOCK WAS RECEIVED. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE AND LEAD. THE PHYSICIAN SUSPECTED THE FALL TO HAVE CAUSED THE LEAD TO HAVE MOVED. A DATA DISK WAS REVIEW BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WHO CONCLUDED THAT NO DAMAGE OR MALFUNCTION OF THE LEAD OR DEVICE OCCURED, AS THIS WAS RELATED TO THE PATIENT'S FALL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313686 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 1861| T167