BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3905599 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12168
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE CLINIC TO HAVE TACHYCARDIA THERAPY PROGRAMMED OFF IN THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PER THE PHYSICIAN'S DIRECTION. UPON INTERROGATION WITH A PROGRAMMER, THE ICD WAS OBSERVED TO BE AT END OF LIFE (EOL) AND IN STORAGE MODE. IT WAS NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP. THE PHYSICIAN INQUIRED IF THE DEVICE COULD BE PROGRAMMED OFF. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THERE ARE NO TACHYCARDIA OR BRADYCARDIA THERAPIES AVAILABLE WHEN IN STORAGE MODE. DEVICE REPLACEMENT WAS NOT SCHEDULED TO BE PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384456 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR 4463| T165| 1861| 0154