BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3211567 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08858
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    February 17, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LEAD SAFETY SWITCH (LSS) INDICATING AN OUT-OF-RANGE (OOR) LOW PACING IMPEDANCE OCCURED. THE LEAD ALSO HAD NOISE PRESENT WHICH NOTED MANY EPISODES OF VENTRICULAR TACHYCARDIA (VT) IN THE ARRYTHMIA LOGBOOK WHICH WERE ALL OVERWRITTEN DUE TO ATRIAL TACHY RESPONSE (ATR) EVENTS. THE DEVICE PROGRAMMING WAS CHANGED TO DDI AND THE PATIENT WILL BE MONITORED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308698 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R S606| 4469| 4087