BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2780547 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13049
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A VENTRICULAR FIBRILLATION (VF) EPISODE THAT RESULTED IN SYNCOPE. THE EPISODE SELF TERMINATED BUT SOME UNDERSENSING WAS NOTED. THE PHYSICIAN DISCUSSED PROGRAMMING THE DEVICE TO BE MORE SENSITIVE. THE PHYSICIAN PLANS TO PERFORM A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) STUDY. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN REPROGRAMMED THE DEVICE TO A MOST SENSITIVE SETTING AND CHANGED THE PATIENT'S MEDICATION. AFTER THESE CHANGES, A DEFIBRILLATION THRESHOLD (DFT) TEST SUCCESSFULLY DETECTED AND CONVERTED THE PATIENT'S VF.

    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 74 YR Hospitalization| L| R 1850| T175| 0148