BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3904752 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-13177
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED FOR AN UNKNOWN PRODUCT PERFORMANCE ISSUE. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382940 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R E110| E142| 4087| 0293| 1850| 0144| T125