BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2053514 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03941
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. 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 THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AND EXHIBITED TONES. THE RECENT MONITORING VOLTAGE MEASUREMENT WAS 2.65 VOLTS WITH A CHARGE TIME MEASUREMENT OF 27.6 SECONDS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

    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 71 YR T167| 0184| 4086