BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3211084 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07887
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MICRODISLODGEMENT OF THE RV LEAD WAS NOTED DURING THE PROCEDURE. THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER RV LEAD OF THE SAME MODEL. THE DEVICE WAS ALSO REPLACED, AS PLANNED, AND AN ATRIAL PACING LEAD WAS ADDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DUE TO THE PROCEDURE. THE EXPLANTED LEAD WAS DISCARDED. 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 THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A PULSATING SENSATION IN THE NECK. THE CLINICIAN BELIEVED IT WAS DUE TO PACEMAKER SYNDROME, AND THE PATIENT WAS SCHEDULED FOR A DEVICE UPGRADE TO A DUAL CHAMBER PACEMAKER. IT WAS ALSO OBSERVED THAT THE RV PACING THRESHOLD MEASUREMENTS HAD INCREASED, AND THAT R-WAVE SENSING HAD DECREASED. A LEAD REVISION WAS PLANNED DURING THE DEVICE REPLACEMENT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310524 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R