BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911347 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15928
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION CONFIRMED INSULATION ABRASION THROUGH TO THE RATE SENSE/DISTAL HIGH VOLTAGE CONDUCTOR CABLE 100-125MM FROM THE TIP. AS THIS IS AN INTEGRATED BIPOLAR LEAD, THE DISTAL HIGH VOLTAGE CONDUCTOR IS ALSO THE RATE SENSE CONDUCTOR, AN INSULATION BREACH THROUGH TO THE SENSING CONDUCTOR AND A FRACTURE OF A SENSING CONDUCTOR COIL COULD RESULT IN NOISE. AS A RESULT, THE CLINICAL OBSERVATIONS WERE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, NOISE WAS NOTED ON THE COMPETITOR RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD. NO INAPPROPRIATE SHOCKS OCCURRED AS A RESULT OF THE NOISE. AS THE PATIENT WAS A NON-RESPONDER TO CARDIAC RESYNCHRONIZATION THERAPY, THE PHYSICIAN ELECTED TO EXPLANT ALL LEADS AND REPLACE WITH ONE RV LEAD. AFTER THE LEADS WERE EXPLANTED, THE RV LEAD NOTED EXTERNALIZATION BETWEEN THE TWO COILS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16502 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 0185