BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2051917 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03555
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    April 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1620-09 TO Z-1621-09
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT TACHY THERAPY WAS PROGRAMMED TO OFF. IT WAS ALSO REPORTED THAT THE DEVICE HAD LIKELY REACHED END OF LIFE DUE TO A CHARGE TIME OF GREATER THAN 30 SECONDS AS THE BATTERY VOLTAGE FOR THE DEVICE WAS 2.29 VOLTS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PULSE GENERATOR (PG) DECLARED END OF LIFE (EOL). AS OF TODAY THE DEVICE REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR T175| 0158