BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1950412 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22454
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SUDDEN IMPEDANCE MEASUREMENT CHANGE AND A LEAD FRACTURE WAS SUSPECTED. RIGHT ATRIAL (RA) LEAD HIGH THRESHOLD MEASUREMENTS WERE ALSO REPORTED. IT WAS REPORTED THAT THE PATIENT WAS VERY PHYSICALLY ACTIVE. THE PATIENT HAD CONCERN ABOUT HAVING A PACING SYSTEM IMPLANTED WITH HIS INCREASED AMOUNT OF ACTIVITY AND THE ENTIRE SYSTEM WAS REMOVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R 4086| 1297| 4087