BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2780193 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12189
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    February 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT SURGICAL INTERVENTION WAS PERFORMED AND THE DEVICE WAS SUCCESSFULLY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER DEVICE WAS NOT IMPLANTED BECAUSE THE PATIENT'S EJECTION FRACTION HAD IMPROVED. THE FIELD REPRESENTATIVE DID NOT HAVE THE EXPLANTED DEVICE, THEREFORE, IT IS UNKNOWN IF IT WILL BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THIS PATIENT WAS TO PROCEED TO ANOTHER FACILITY FOR A POSSIBLE DEVICE CHANGE-OUT AS THE DEVICE WAS THOUGHT TO BE AT END OF LIFE (EOL). HOWEVER, THE FIELD REPRESENTATIVE REPORTED THIS PATIENT HAS NOT YET BEEN SEEN. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    RESOLUTION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED. THIS DEVICE HAD NOT BEEN CHECKED IN NEARLY FIVE YEARS. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING. NO TONES WERE NOTED WITH MAGNET APPLICATION AND THE PATIENT HAD NOT RECALLED HEARING TONES IN THE PAST. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW 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 39 YR 0147| 1853| 4470| T125