BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3770438 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09236
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CAME INTO THE EMERGENCY ROOM THE SAME DAY OF BEING DISCHARGED FROM ANOTHER HOSPITAL AFTER HER IMPLANT PROCEDURE. THE PATIENT HAD PASSED OUT AND EVALUATION OF THE SYSTEM NOTED FAR-FIELD R OVERSENSING ON THE ATRIAL CHANNEL. THE CALLER WAS QUESTIONING THE FUNCTIONALITY OF THE ATRIAL LEAD. THE SENSITIVITY WAS REPROGRAMMED TO CORRECT THE OVERSENSING AND NORMAL FUNCTION WAS OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249918 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 4087| K173| 4086