BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1042643 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33998
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 25, 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
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    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 CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEEPING FOR OUT OF RANGE SHOCK IMPEDANCE >125 OHMS. FURTHER TESTING IN THE CLINIC CONFIRMED SHOCK IMPEDANCE WAS 45-65 OHMS. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT PERHAPS THE SETSCREW INVOLVING THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD MAY NOT BE FULLY TIGHTENED. IT WAS LATER REPORTED THAT THE PHYSICIAN REOPENED THE POCKET AND DISCOVERED HE HAD NOT TIGHTENED THE DEFIBRILLATION NEGATIVE SETSCREW. THE PIN FELL OUT OF THE DEVICE WHEN IT WAS REMOVED FROM THE POCKET. THE SETSCREW WAS TIGHTENED AND THE DEVICE AND LEAD WERE FUNCTIONING APPROPRIATELY. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R THE DEVICE 0185/177580 WAS IMPLANTED| THE DEVICE 0185| THE DEVICE 4470/572237 WAS IMPLANTED 20-FEB-2008| THE DEVICE 4470/572237 WAS IMPLANTED (B)(6) 2008| THE DEVICE 0185/177580| THE DEVICE 0185/ WAS IMPLANTED