BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213616 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09208
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED A KINKED STYLET RETURNED INSERTED IN THE LEAD WITH CUT NOTED IN THE INSULATION FROM TERMINAL PIN. PRODUCT ANALYSIS CONFIRMED THAT THE LEAD INSULATION HAS BEEN CUT WHICH CAUSED THE PRESENCE OF BLOOD FLUID IN THE LUMENS. ADDITIONAL ANALYSIS WAS PERFORMED DUE TO NEWLY ADDED ALLEGATION. LEAD DISLODGEMENT COULD NOT BE CONFIRMED BY ANALYSIS. THE LEAD TIP AND HELIX HAVE NO VISIBLE SIGNS OF DAMAGE OR DEFECT WHICH WOULD LEAD TO DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) INSULATION LEAD WAS DISSECTED INTENTIONALLY IN ORDER FOR THE GUIDEWIRE TO BE INSERTED INTO THE VESSEL MAINTAINING THE VENOUS ACCESS. ADDITIONAL INFORMATION CONFIRMED THIS RV LEAD WAS ALSO DISLODGED, SO THE PHYSICIAN DECIDED TO REPLACED IT. THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313500 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 0184| 4473| E143