BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4145564 · Received October 6, 2014

    Report

    Report Number
    2124215-2014-17824
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH ANALYSIS WAS PERFORMED. THE PRODUCT ANALYSIS INDICATED THAT UPON VISUAL EXAMINATION, IT WAS NOTED THAT THE LEAD BODY WAS TWISTED, SOME SETSCREW MARKS WERE NOTED ON THE TERMINAL PIN, A TISSUE WAS NOTED IN THE RETRACTED HELIX AND A DRIED BLOOD/BODY FLUID WAS NOTED IN THE HELIX HOUSING. THE LEAD PASSED ELECTRICAL TESTING. IN CONCLUSION, THE LEAD WAS CLINICALLY OUT OF SPECIFICATIONS DUE TO CLOGGING THAT WAS INDUCED IN THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. UPON DEVICE CHECK, THE PHYSICIAN NOTED THAT THE SLACK OF THIS RV LEAD WAS PULLED BACK AND THERE WAS INCREASE IN THRESHOLD AND DECREASE IN R WAVES. A REVISION PROCEDURE WAS PERFORMED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE RV LEAD BUT THERE WAS DIFFICULTY RETRACTING THE HELIX AND WAS UNSUCCESSFUL BECAUSE OF PLACEMENT DIFFICULTY DUE TO PATIENT ANATOMY. ADDITIONALLY, A TISSUE WAS NOTED IN THE RETRACTED HELIX. THE RV LEAD WAS EXPLANTED, REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624826 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R N160| 4592| 0293| 4543| 4136