BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1771619 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13787
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 14, 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 Location
    KY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS DEVICE HAS BEEN ELECTRICALLY RE-PROGRAMMED TO MONITOR ONLY. THIS DEVICE HAS NOT BEEN EXPLANTED OR RETURNED TO THE BOSTON SCIENTIFIC CRM POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS PURPOSES. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY AND INITIALLY COMMUNICATED ON (B)(6) 2007, EXHIBITED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A CHARGE TIME MEASUREMENT EXCEEDING NORMAL LIMITS. THIS DEVICE WAS SUBSEQUENTLY DEACTIVATED DUE TO THE PATIENT'S MOVE TO HOSPICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THESE CLINICAL OBSERVATIONS.

    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 78 YR 6943| T135| 1793