BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1946100 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20291
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    September 30, 2010
    Report Date
    December 10, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    NOTAPVD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION WAS PERFORMED AND THIS LEAD WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE THE LEAD HAS BEEN RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION NOTED A CUT IN THE INSULATION APPROXIMATELY 15 CENTIMETERS FROM THE TERMINAL PIN AND THERE WAS BLOOD INFILTRATION IN THE HELIX HOUSING. TESTING OF THE INNER INSULATION WAS PERFORMED AND FAILED. THE OUTER INSULATION WAS CUT OPEN AND DAMAGE WAS NOTED IN THE INNER INSULATION ABOUT 54 CENTIMETERS FROM THE TERMINAL PIN. NO IRREGULARITIES WERE NOTED IN THE OUTER INSULATION ABOVE THIS ABRASION SITE. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THIS TEST WAS WITHIN NORMAL LIMITS, INDICATING THAT THE CONDUCTOR COIL HAD NOT FRACTURED. THE TYPE OF DAMAGE NOTED IN THE INNER INSULATION IS CONSISTENT WITH HAVING OCCURRED DUE TO A REPEATED STRESS OVER TIME. LABORATORY ANALYSIS CONFIRMED THAT THE LEAD HAD BEEN DAMAGED, BUT THE TYPE OF DAMAGE WAS NOT DUE TO CLAVICULAR FIRST RIB CRUSH, BUT RATHER BY REPETITIVE STRESS. HOWEVER, ANALYSIS WAS UNABLE TO CONFIRM THAT THE LEAD COULD NOT DELIVER PACING. THE LEAD WAS FOUND TO BE ELECTRICALLY CONTINUOUS AND WOULD HAVE BEEN ABLE TO PROVIDE PACING PULSES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A PATIENT FOLLOW UP, IT WAS NOTED ON THE HOLTER MONITOR THAT THIS RIGHT VENTRICULAR (RV) LEAD DID NOT ALWAYS PROVIDE PACING. ALL MEASUREMENTS TAKEN ON THIS LEAD WERE WITHIN NORMAL PARAMETERS. HOWEVER, WHEN THE PATIENT TRIED TO STAND UP, ASYSTOLE WAS NOTED ON THE MONITOR AND THE PATIENT REPORTED FEELING DIZZY. NO ADVERSE PATIENT EFFECTS WERE REPORTED BUT THIS PATIENT IS PACEMAKER DEPENDENT. IT IS SUSPECTED THAT THE LEAD HAS BEEN DAMAGED THROUGH CLAVICULAR-FIRST RIB CRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4096| 4097| 1294