BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2910786 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16241
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DURING ROUTINE REPLACEMENT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE HEADER WAS OBSERVED TO BE A LITTLE LOOSE UPON REMOVING THE DEVICE FROM THE POCKET. IT WAS REPORTED THAT A CLAMP WAS USED TO REMOVE THE DEVICE FROM THE POCKET AND WHEN PRESSURE WAS APPLIED TO THE HEADER WITH THE CLAMP, THE HEADER MOVED A LITTLE BIT. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16564 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4470| E143| T165| 0185