BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 4221028 · Received November 3, 2014

    Report

    Report Number
    2124215-2014-18485
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    February 19, 2013
    Report Date
    August 26, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. DRAINAGE FROM THE PATIENT'S INCISION SITE WAS OBSERVED AND WAS DETERMINED THAT THE DEVICE WAS INFECTED. THIS RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE STATES THAT THE LEAD FRACTURE WAS CONFIRMED VIA FLUOROSCOPY AND WAS FOUND IN THE REGION OF THE CLAVICLE AND FIRST RIB. THE RV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702278 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| L| R 7288| 1861| MISMATCH| 6947| 0154| 4470| 4473