BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3803238 · Received May 9, 2014

    Report

    Report Number
    2124215-2014-10499
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 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
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD FOUND THAT THE HELIX MECHANISM WAS RETRACTED AND DRIED BLOOD/TISSUE WAS NOTED IN THE HELIX HOUSING. AFTER REMOVING THE DRIED BODY FLUID/TISSUE, THE HELIX MECHANISM WAS FULLY FUNCTIONAL. BASED UPON THE CLINICAL OBSERVATIONS AND THE LABORATORY FINDINGS, WE BELIEVE THAT BODY FLUID AND/OR TISSUE INSIDE THE HELIX HOUSING CAUSED THE IRREGULARITY IN HELIX FUNCTION. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS WAS UNABLE TO REPRODUCE THE REPORTED LOSS OF CAPTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A HEMATOMA EVACUATION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUTS DUE TO A POSSIBLE PERFORATION. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO REPOSITION THE LEAD HOWEVER THE HELIX COULD NOT BE EXTENDED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281547 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 0180| E143| 4470