BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041109 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01699
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE LEAD WAS RETURNED SEVERED AT 68 MM FROM THE TERMINAL PIN WITH ONLY THE PROXIMAL END OF THE IS-1 TERMINAL LEG BEING RETURNED. BLOOD AND BODY FLUID WERE OBSERVED ON THE TERMINAL PIN AND TERMINAL MOLDING AND THE INSULATION WAS FOUND TO BE CUT AND TORN AROUND THE CIRCUMFERENCE 24 MM FROM THE TERMINAL PIN. FURTHER VISUAL INSPECTION FOUND A SEPARATION IN THE INSULATION AND STRETCHED CONDUCTOR COILS FROM APPROXIMATELY 20 TO 60 MM FROM THE TERMINAL PIN. ANALYSIS DETERMINED THAT ALL DAMAGE APPEARED TO BE RELATED TO THE EXPLANT PROCEDURE. THE RETURNED LEAD SEGMENT WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THIS PORTION OF THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. THE LABORATORY ANALYSIS SPECULATED THAT IT IS POSSIBLE THAT BLOOD AND BODY FLUID IF IT INGRESSES INTO THE DEVICE PORT WHERE THE TERMINAL PIN IS LOCATED, COULD ACT LIKE A GLUE AND CAUSE THE TERMINAL END TO BE STUCK INSIDE THE DEVICE HEADER. HOWEVER, ANALYSIS WAS NOT ABLE TO CONFIRM THE FIELD ALLEGATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT PROCEDURE FOR NORMAL BATTERY DEPLETION, THE RIGHT VENTRICULAR (RV) LEAD AS WELL AS THE COMPETITIVE RIGHT ATRIAL (RA) LEAD WERE NOTED TO BE STUCK IN THE HEADER OF THE DEVICE. THE PHYSICIAN ENSURED THAT ALL EIGHT SETSCREWS WERE LOOSENED WITH NO SUCCESS. WHEN REMOVING THE COMPETITIVE RA LEAD THE PHYSICIAN TUGGED SO HARD THAT THE TERMINAL PIN BECAME DETACHED FROM THE LEAD AND REMAINED IN THE HEADER. IN ORDER TO REMOVE THE RV LEAD, THE PHYSICIAN CUT IT OUT OF THE DEVICE HEADER. BOTH LEADS WERE SURGICALLY ABANDONED AND THEN EXPLANTED THE FOLLOWING DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143001 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 1298| H179| 1823| 4513| 0157| 1488TC