BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3212675 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09870
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 31, 2013
    Report Date
    March 23, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, THE RV LEAD AND PACEMAKER REMAIN 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 DURING A ROUTINE DEVICE FOLLOW UP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCE MEASUREMENTS, FROM 860 OHMS PREVIOUSLY TO 2060 OHMS CURRENTLY. ALSO, THE PACING THRESHOLD MEASUREMENTS HAD INCREASED. A LEAD FRACTURE WAS SUSPECTED. AN X-RAY WAS PERFORMED AND NO VISIBLE DAMAGE TO THE LEAD WAS OBSERVED. THE LEAD WAS THEN TESTED IN THE UNIPOLAR CONFIGURATION, WHERE THE IMPEDANCE AND THRESHOLD MEASUREMENTS WERE WITHIN NORMAL RANGE. IT WAS THEN DECIDED TO LEAVE THE LEAD IN THE UNIPOLAR CONFIGURATION AND INCREASE FOLLOW-UPS TO EVERY THREE MONTHS. NO LEAD REVISION WAS PLANNED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN TO CHECK THE DEVICE PRIOR TO RECEIVING RADIATION THERAPY. WHEN THE DEVICE WAS INTERROGATED, THERE WAS A RECORDED EPISODE WHERE NOISE ON THE RIGHT VENTRICULAR CHANNEL WAS OVERSENSED AND CAUSED PACING INHIBITION FOR ABOUT THREE SECONDS. THE NOISE CORRESPONDED TO A RECENT NON-DEVICE RELATED PROCEDURE THAT THE PATIENT HAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS TRANSFERRED TO ANOTHER CENTER WHERE THE PATIENT WILL RECEIVE RADIATION THERAPY SO THEY CAN MONITOR AND ADJUST THE DEVICE PROGRAMMING ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312309 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR S601| 4088