BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3050153 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05223
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED A BATTERY STATUS ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES OUTSIDE OF THE EXTENDED CHARGE TIME LIMIT FOR THE DEVICE. THE DEVICE THEN SUBSEQUENTLY DECLARED END OF LIFE (EOL). THE PATIENT WAS SEEN FOR A DEVICE REPLACEMENT PROCEDURE WHERE THE DEVICE WAS EXPLANTED. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE DEVICE WOULD NOT BE RETURNED FOR ANALYSIS AS IT WAS KEPT BY THE HOSPITAL. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149583 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 0158| T177| E161| 1852