BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3935994 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13892
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED DUE TO LOW PACING IMPEDANCES OF LESS THAN 200 OHMS, AS WELL AS NO PACING IN THE BIPOLAR CONFIGURATION. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413434 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 1297| K173| 4137| 4087| 4088