BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 4140457 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17595
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 FROM THE PATIENT'S DAUGHTER THAT THIS DEVICE WAS NOT WORKING PROPERLY. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REPORTED THAT A LEAD REVISION WAS PERFORMED TO REPLACE A RIGHT VENTRICULAR (RV) LEAD THAT EXHIBITED LOSS OF CAPTURE. ALL MEASUREMENTS WERE IN NORMAL RANGE WITH THE NEWLY IMPLANTED RV LEAD. LATER THAT SAME DAY, THE RV LEAD PRESENTED WITH LOSS OF CAPTURE. ANOTHER FOLLOW UP WAS PERFORMED THE NEXT DAY AND NOISE AND INTERMITTENT CAPTURE WAS NOTED WITH THE RV LEAD. THE PATIENT WAS KEPT IN THE HOSPITAL FOR OVER A WEEK AND THE SAME OBSERVATIONS WERE NOTED DURING EACH FOLLOW UP. AN ISSUE WAS SUSPECTED WITH THE PACEMAKER AND ANOTHER REVISION WAS PERFORMED. DURING THE PROCEDURE, IT WAS NOTED THAT ALTHOUGH THE RV LEAD WAS INSERTED INTO THE PORT, THE PACEMAKER'S SETSCREW WAS NOT ENGAGED. THE PACEMAKER WAS REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. THE RV LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618783 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R S403| 4087| 4088