BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2041711 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02706
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION NOTED NO DISCREPANCIES WITH THE DEVICE HEADER OR LEAD PORTS. A REVIEW OF THE AS RECEIVED MEMORY SHOWS THE ATRIAL LEAD IMPEDANCE VALUE WAS APPROXIMATELY 1320 OHMS AT IMPLANT, BUT INCREASED TO 1970 OHMS BY THE WEEK OF (B)(4), 2010. THE VENTRICULAR LEAD APPEARED STABLE AT 1030 OHMS OVER THE LAST YEAR OF IMPLANT. DEVICE MEMORY ALSO SHOWS A ZOOM FORCED LEAD TEST IN THE FIELD ON (B)(6), 2011, MEASURED GREATER THAN 2500 OHMS IMPEDANCE IN THE ATRIAL CHAMBER AND 1150 OHMS IN THE VENTRICULAR CHAMBER. THE DEVICE FUNCTIONED WITHIN ELECTRICAL SPECIFICATIONS DURING ANALYSIS. THERE ARE NO INDICATIONS IN THE AS RECEIVED MEMORY THAT THE DEVICE FAILED TO OPERATE IN SPECIFICATION AND DELIVER THERAPY AS PROGRAMMED. 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'S ATRIAL LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. THE LEAD AND THIS PACEMAKER WERE BOTH REMOVED FROM SERVICE AS THE CAUSE OF THE OUT OF RANGE IMPEDANCES COULD NOT BE DETERMINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 4472| S606| 1290| 4053| 4054