BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 4132357 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-16941
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED IN TWO SEGMENTS AND SEVERED 170 MILLIMETERS (MM) FROM THE TERMINAL PIN. ADDITIONALLY, THE RS- CONDUCTOR COIL WAS NOTED TO BE STRETCHED. AN X-RAY WAS PERFORMED ON BOTH SEGMENTS AND NO ADDITIONAL ANOMALIES WERE NOTED. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING CONFIRMED THE STRETCHED COILS HOWEVER WAS UNABLE TO REPRODUCE THE ADDITIONAL CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM ANOTHER MANUFACTURER THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD PRESENTED FOR LEAD EXTRACTION. IT WAS REPORTED THE RATE/SENSE PORTION OF THIS LEAD HAD PREVIOUSLY BEEN SURGICALLY ABANDONED. THE SHOCK IMPEDANCE MEASUREMENTS WERE VARYING AND THE PHYSICIAN ELECTED TO REMOVE THE LEAD. DURING THE PROCEDURE A SMALL PERICARDIAL EFFUSION WAS OBSERVED. AN ATTEMPT TO PLACE THE NEW LEAD WAS MADE, HOWEVER IT WAS NOTED THE PERICARDIAL EFFUSION WAS LARGER. A PERICARDIAL WINDOW WAS CREATED WHICH RESOLVED THE PERICARDIAL EFFUSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612233 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R 1861| 4087| MISMATCH| 0154