BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTEND II

    MDR report key: 3192118 · Received June 27, 2013

    Report

    Report Number
    2124215-2013-10150
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING PRODUCT RETURN AND COMPLETION OF LAB ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY FOLLOWING A COMPLICATED LEAD IMPLANT, LOSS OF CAPTURE, HIGH PACING THRESHOLDS AND IMPEDANCE ISSUES WERE EXHIBITED. THE PHYSICIAN ATTEMPTED A LEAD REPOSITION; HOWEVER, THE EFFORT WAS UNSUCCESSFUL AND THE LEAD WAS EXPLANTED. THE PHYSICIAN SUSPECTED A MALFUNCTION OF THE LEAD'S FIXATION MECHANISM. A COMPETITOR LEAD WAS SUCCESSFULLY IMPLANTED BUT FAILED TO SHOW IMPROVEMENTS. THE PATIENT PASSED AWAY THE FOLLOWING MORNING; THE CAUSE OF DEATH WAS NOT REPORTED. THE FIELD REPRESENTATIVE STATED THE PATIENT'S HEALTH WAS UNWELL, WITH A CONFIRMED LOW EJECTION FRACTION. THE LEAD IS INTENDED TO BE RETURNED FOR A POST MARKET ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292740 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R