BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1042357 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34284
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 30, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A SHOCKING LEAD IMPEDANCE (SLI) MEASUREMENT OF GREATER THAN 125 OHMS. THE SLI AT IMPLANT WAS 65 OHMS AND THE CALLER REPORTED THAT IT HAS GRADUALLY INCREASED SINCE THEN. AT THE TIME OF THE CALL THE SLI WAS 77 OHMS. A SETSCREW REVISION WAS MADE, A 1.1 J SHOCK WAS ADMINISTERED AND DEFIBRILLATION TESTING WAS PERFORMED. SLI MEASUREMENTS AFTER THIS PROCEDURE WERE IN THE 40 OHM RANGE. ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS DEVICE WAS EXPLANTED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| O| R THE DEVICE (B)(4)| THE DEVICE 0184/144833 WAS IMPLANTED 29-JAN-2008