BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3904152 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-07416
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    December 1, 2013
    Report Date
    May 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    NOTAPVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE BEING MADE. SHOULD ADDITIONAL INFORMATION BE MADE AVAILABLE, THIS REPORT WILL BE UPDATED.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. IT WAS REPORTED THAT THE SENSING WAS WITHIN NORMAL LIMITS AND THERE WAS NO NOISE EXHIBITED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE CLINICAL OBSERVATION AND POSSIBLE SOURCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THE RATE/SENSE LEAD WAS SURGICALLY CAPPED AND ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382911 FLEXTEND II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 4097| 1871| 1831| 0145