BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2911996 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16856
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    January 27, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    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 THE 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 THE PATIENT EXPERIENCED A FEW INSTANCES OF SYNCOPE FOR AN UNKNOWN REASON. WHEN ATTEMPTING TO INTERROGATE THE PACEMAKER, THE CLINICIAN WAS UNABLE TO OBTAIN ATRIAL IMPEDANCE VALUES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THAT SINCE THE PATIENT WAS IN ATRIAL FIBRILLATION IMPEDANCE VALUES WOULD BE UNABLE TO BE MEASURED UNLESS THE DEVICE WAS PROGRAMMED DOO. ONCE THE CLINICIAN TEMPORARILY PROGRAMMED THE PACEMAKER DOO, IMPEDANCE VALUES WERE SUCCESSFULLY OBTAINED. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION RELATING TO THE REASON FOR THE PATIENT'S SYNCOPE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16672 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening 4137| 1290| 4136