BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1874939 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17955
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD IS UNDERGOING ANALYSIS. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED DRIED BLOOD IN THE HELIX MECHANISM UP THROUGH THE LUMEN. THE INNER AND OUTER CONDUCTOR COILS WAS STRETCHED 330 - 700 MILLIMETERS. THE CONDUCTOR COILS WERE DEFORMED 250 MILLIMETERS FROM THE TERMINAL PIN. THERE WERE CUTS FOUND IN THE INSULATION AT 724 AND 725 MILLIMETERS AND THE SILICONE INSULATION WAS ROLLED BACK AT 745 MILLIMETERS. THE INSULATION BETWEEN THE ANODE RING AND THE HELIX HOUSING WAS ALSO STRETCHED. THE INNER INSULATION HAD AN OBLONG HOLE IT. ANALYSIS CONCLUDED THAT THE HOLE IN THE INSULATION WAS LIKELY DUE TO THE EXTENSIVE STRETCHING AND DEFORMATION OF THE LEAD DURING EXPLANT. RESISTANCE AND PRESSURE TEST WERE USED TO TEST ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD BECAME DISLODGED. IT WAS NOTED THAT THE PATIENT HAD NOT HAD REGULAR FOLLOW-UP VISITS SO, THE PHYSICIAN BELIEVES THE LEAD HAD BEEN DISLODGED FOR SOME TIME. THERE WAS NO CAPTURE ON THE RA AND FLUOROSCOPE SHOWED THAT THE RA LEAD HAD DROPPED INTO THE VENTRICLE. THE IMPEDANCE MEASUREMENTS WERE STABLE. THE PHYSICIAN ATTEMPTED TO RE-POSITION THE LEAD; HOWEVER, HE WAS UNABLE TO OBTAIN A GOOD LOCATION. THE LEAD WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 1861| 4087| 0158