BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2163137 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07373
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS CAPPED AND SURGICALLY ABANDONED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR PACING LEAD PRESENTED TO THE EMERGENCY ROOM DUE TO EXPERIENCING SYNCOPE. AN ELECTROCARDIOGRAM REVEALED INTERMITTENT DROPPED BEATS. IT WAS REPORTED THAT THE PATIENT IS PACER DEPENDENT, THEREFORE A TEMPORARY PACING WIRE WAS PLACED. THE DEVICE IMPLANTED WITH THIS LEAD WAS THEN INTERROGATED AND IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS WERE OBSERVED ALONG WITH NOISE. THERE WAS CONCERN THE LEAD HAD FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS SUCCESSFULLY CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 4088| MISMATCH| S601| 1190