BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1954234 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24713
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IMPLANTED. THE INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID DELIVER INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SEVEN SHOCKS, EXHAUSTING THERAPY. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT CONFIRMED WITH THE HEALTH CARE PERSONNEL THAT THERE WAS NO EVIDENCE THAT THERAPY WAS DELAYED AS A RESULT OF DETECTION ENHANCEMENT PROGRAMMING. THE PATIENT WAS TO HAVE AN SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION THE VERY NEXT DAY. THE TECHNICAL SERVICES CONSULTANT INSTRUCTED THE MEDICAL PERSONNEL IN PROGRAMMING CHANGE TO MITIGATE THE ISSUE AND ENSURE SUDDEN RATE DETECTION WAS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 7000| 5076| T167