BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3936132 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13577
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE CONDUCTOR COILS WERE SLIGHTLY DEFORMED NEAR THE TERMINAL END AND THE INSULATION SLEEVE WAS WAVY NEAR THE TIP. ANTI-ADHESION WAS EXTREMELY BUNCHED IN SEVERAL PLACES AND THE LEAD BODY WAS CURLED. THE LEAD WAS STUCK IN AN INTRODUCER WITH A BEND IN IT UPON RECEIPT AT LABORATORY. THE DAMAGE ON THIS LEAD IS CONSISTENT WITH A LEAD WHICH HAS BEEN PLACED THROUGH A CONSTRICTED AREA.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PLACEMENT DIFFICULTY WAS MET DURING THE IMPLANT PROCEDURE, AFTER THE RIGHT VENTRICULAR (RV) LEAD WAS PASSED THROUGH THE SHEATH SEVERAL TIMES. RV LEAD HAD CONDUCTOR AND TERMINAL END DAMAGE THAT WAS NOTED UPON VISUAL INSPECTION. THIS LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412665 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR E142| 0293| MISMATCH