BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3921803 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11469
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOLLOW UP CHECK, RIGHT ATRIAL (RA) LEAD FRACTURE WAS SUSPECTED AND ATRIAL LEAD SAFETY SWITCH (LSS) HAS OCCURRED. AN ELECTROGRAM (EGM) WAS PERFORMED BUT UNABLE TO SEE P-WAVES AT VVI 30. ALSO, ATRIAL TACHY RESPONSE (ATR) EPISODES WITH NOISE WERE OBSERVED THAT WAS RECREATED WITH ISOMETRICS. HENCE, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) HAD THE FIELD REPRESENTATIVE RESET LSS AND TRACKED IMPEDANCE AND A GREATER THAN 2,500 OHMS PACING IMPEDANCE MEASUREMENT WAS DETECTED. THE FIELD REPRESENTATIVE COULD NOT PROVIDE ANY FURTHER INFORMATION ON THIS CASE. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400442 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 1294| 4087| 4088| S603