BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3904501 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09208
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. 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 POST RIGHT VENTRICULAR LEAD REPOSITIONING, WHEN THE PATIENT WITH THIS ATRIAL LEAD WAS BEING MOVED TO A STRETCHER, FARFIELD OVERSENSING WAS OBSERVED AND FALLING INTO THE BLANKING PERIOD. ATRIAL SIGNALS ALIGNED WITH THE VENTRICULAR ELECTROGRAM SIGNALS. THE LEAD WAS RETESTED REVEALING NO CAPTURE AT MAXIMUM OUTPUTS. THE DEVICE WAS PROGRAMMED TO VVI PACING MODE. AN X-RAY CONFIRMED THIS LEAD WAS DISLODGED. A DECISION WAS MADE TO NOT PERFORM A LEAD REVISION. IT WAS THOUGHT THE LEAD MAY BE RESTING IN THE CORONARY SINUS. THE DEVICE REMAINS PROGRAMMED TO VVI. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384029 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 4088| 4087| K183