BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1853586 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15010
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EXTENDED CHARGE TIMES. THE DEVICE IS TO BE EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS A PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 4086| 0157| T125