BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3210973 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07736
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    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

    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 (RV) LEAD WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING A FALL AND ABDOMINAL PAIN. A DEVICE CHECK WAS PERFORMED, WHICH REVEALED FIVE BEATS OF NON-CAPTURE HAD OCCURRED. AN X-RAY SHOWED THE DEVICE HAD MOVED AND THE LEAD NO LONGER HAD ANY SLACK. PACING THRESHOLD MEASUREMENTS HAD INCREASED AND PACING IMPEDANCE MEASUREMENTS HAD DECREASED. A MICRODISLODGEMENT WAS SUSPECTED BUT NOT CONFIRMED. A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE CHRONIC DEVICE REMAINS IN SERVICE WITH THE NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310514 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4088| S601