BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 3922021 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13516
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING LEAD IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATED THAT THE CAUSE WAS NOT DETERMINED. THE ICD WAS EXPLANTED AND THE RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401580 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R E140| 0285| T135| 0147