BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3213170 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09991
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED HIGH OUT OF RANGE SHOCK IMPEDANCES ON THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD. ALL OTHER RV LEAD MEASUREMENTS WERE STABLE AND WITHIN NORMAL LIMITS. SURGICAL INTERVENTION WAS PERFORMED AND AFTER REMOVING THE LEAD FROM THE HEADER AND REINSERTING IT THE SHOCK IMPEDANCE MEASUREMENTS WERE STILL HIGH AND OUT OF RANGE. VISUAL INSPECTION CONFIRMED THAT THE TERMINAL PIN WAS NOT FULLY INSERTED INTO THE HEADER OF THE DEVICE. TECHNICAL SERVICES ADVISED TO USE STERILE SALINE TO LUBRICATE THE LEAD. AFTER DOING THIS THE TERMINAL PIN FULLY ENGAGED WITH THE HEADER OF THE DEVICE AND THE SHOCK IMPEDANCE MEASUREMENTS RETURNED TO AN ACCEPTABLE RANGE. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313392 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E161

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R S601| 4471| E161| 0180