BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 4132227 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15656
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 23, 2014
    Report Date
    October 7, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOWING COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. X-RAY EXAMINATION OF THE DEVICE DETERMINED THE RIGHT VENTRICULAR (RV) RING COIL SPRING WAS MISSING. THIS RESULTED IN THE OBSERVED OUT-OF-RANGE MEASUREMENTS. THE ANOMALY HAS BEEN REPORTED TO OUR ENGINEERING AND MANUFACTURING DEPARTMENTS. WE WILL CONTINUE TO MONITOR FIELD OBSERVATIONS FOR SIMILAR REPORTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS DEVICE, HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED AFTER SETSCREW CONNECTION WAS ESTABLISHED. THE ISSUE WAS UNRESOLVED AND THE DEVICE WAS REMOVED FROM THE PROCEDURE; ANOTHER DEVICE WAS THEN SELECTED TO COMPLETE THE IMPLANT PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED AND THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613119 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E160

    Patients

    Seq Age Sex Outcome Treatment
    1 E160| 0292