BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1871131 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17303
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 25, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EMITTING BEEP TONES. UPON INTERROGATION, IT WAS IDENTIFIED THAT THIS DEVICE HAD DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED DUE TO LONGER THAN NORMAL CHARGE TIMES DURING MIDDLE OF LIFE. EMITTING BEEP TONES. THE DEVICE WAS EXPLANTED FOR AND REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 0175| T135