BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 4210018 · Received October 29, 2014

    Report

    Report Number
    2124215-2014-19069
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    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 AN INTEROGATION TWO DAYS POST IMPLANT, A CHECK RIGHT VENTRICULAR (RV) LEAD MESSAGE DISPLAYED FOR AN UNKNOWN REASON. ALL LEAD MEASUREMENTS TESTED NORMAL AND PATIENT WAS DISCHARGED. THE LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692026 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR K173| 4086| 4469| 4087