BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3905625 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12022
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 1, 2012
    Report Date
    May 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THIS DEVICE WILL NOT BE AVAILABLE FOR RETURN. 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE RIGHT ATRIAL (RA) PACING IMPEDANCE MEASUREMENTS ALONG WITH HIGH PACING THRESHOLD MEASUREMENTS. IT WAS REPORTED THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS AND THRESHOLD MEASUREMENTS HAD ALSO INCREASED, HOWEVER REMAINED WITHIN RANGE. AN INVASIVE PROCEDURE WAS PERFORMED. THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384838 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 0185| 4470| T165