BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3041061 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01409
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA LEAD REMAINS IN SERVICE FOR SENSING. 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 ATRIAL (RA) LEAD WAS SEEN IN THE CLINIC FOR A ROUTINE FOLLOW-UP. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REVIEWED THE PATIENT'S CHART AND FOUND A NOTE STATING THAT THIS LEAD HAD DISLODGED ONE DAY POST-IMPLANT. NO SENSING OR CAPTURE WAS OBSERVED. THE DEVICE WAS REPROGRAMMED TO VVI PACING MODE, AND THE PATIENT WAS SEEN THREE DAYS LATER FOR EVALUATION. THE ATRIAL LEAD WAS SENSING APPROPRIATELY, WITH NO CAPTURE. THE DEVICE WAS THEN REPROGRAMMED TO VDD PACING MODE. NO ADVERSE PATIENT EFFECTS OCCURRED DUE TO THE ATRIAL LEAD DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142874 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1