BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1771618 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13586
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    July 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, THE DEVICE WAS ANALYZED. A REVIEW OF DEVICE MEMORY REVEALED THE DEVICE HAD GONE TO FACTORY FALLBACK MODE DUE TO SIX WARM RESETS THAT OCCURRED DURING A CHARGE. ANALYSIS CONCLUDED THE RESETS AND FACTORY FALLBACK MODE HAPPENED POST-EXPLANT WITH NO LEADS ATTACHED TO THE DEVICE. THE DEVICE PROGRAM CODE WAS SUCCESSFULLY RELOADED AND FURTHER TESTING FOUND THE DEVICE COULD PACE, SENSE, AND DELIVER SHOCK THERAPY ONCE THE PROGRAM MEMORY WAS RELOADED

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS ONGOING. AN UPDATED REPORT WILL BE SUBMITTED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    ANALYSIS CONCLUDED THE DEVICE HAD THERAPY AVAILABLE WHILE IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS RETURNED WITH NO ALLEGATION. INITIAL ROUTINE DEVICE ANALYSIS FOUND THE DEVICE WAS IN FACTORY FALLBACK MODE WITH NO THERAPY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1870

    Patients

    Seq Age Sex Outcome Treatment
    1