BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2153499 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06090
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM AND ATRIAL IMPEDANCE MEASUREMENTS WERE GREATER THAN 3000 OHMS AND LOSS OF CAPTURE WAS NOTED. THEREFORE, A REVISION PROCEDURE WAS PERFORMED. THE POCKET WAS OPENED AND IT WAS REVEALED THAT THE DISTAL SETSCREW ON THE ASSOCIATED IMPLANTABLE PULSE GENERATOR (IPG) WAS LOOSE AND IN THE FULLY EXTENDED/UP POSITION. THE SETSCREW WAS TIGHTENED DOWN AND LEAD IMPEDANCES WERE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR T125| 0158| 4136