BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 4140021 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17276
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. UPON INTERROGATION, A MESSAGE INDICATED LOW OUT OF RANGE IMPEDANCE MEASUREMENTS WAS DETECTED AND ERI WAS REACHED AS WELL. REVIEW OF DAILY MEASUREMENTS REVEALED BOTH PACE AND SHOCK IMPEDANCE MEASUREMENTS WERE OUT OF RANGE. ADDITIONALLY, LOSS OF CAPTURE AT MAXIMUM OUTPUT WAS NOTED. AN INVASIVE PROCEDURE WAS PERFORMED. THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620696 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R T175| 0180| 0147| 1860