BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1950508 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22641
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1513-08 TO Z-1514-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED. BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THE REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REPLACEMENT PROCEDURE WAS PERFORMED, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS REMOVED. DURING A FOLLOW UP VISIT, INTERROGATION REVEALED THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATORS (ERI). THERE WAS CONCERN THAT THE BATTERY HAD DEPLETED MORE RAPIDLY THAN EXPECTED. THE DEVICE WAS REPLACED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO RETURN OF PRODUCT IS INTENDED.

    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 Required Intervention