BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911349 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16089
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS CURRENTLY BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED BLOOD IN THE HELIX MECHANISM. TESTING CONFIRMED THE DAMAGE OCCURRED DURING THE EXPLANT PROCEDURE AND MOST LIKELY CONTRIBUTED TO THE HELIX EXTENSION DIFFICULTY OBSERVED CLINICALLY. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING ELEVATED THRESHOLDS AND WAS FOUND TO HAVE PERFORATED THROUGH THE MYOCARDIUM INTO THE PERICARDIUM WITHIN A COUPLE DAYS POST-IMPLANT. THE PATIENT REQUIRED A PERICARDIAL DRAIN IN A RATHER EMERGENT SITUATION. A REVISION PROCEDURE WAS PERFORMED AND EFFORTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL AS THE HELIX WOULD NOT RE-EXTEND. THEREFORE, THE LEAD WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18141 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 0293| E140