BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1864226 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16133
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 4, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, VISUAL INSPECTION INDICATED THERE WERE SET SCREW MARK ON ALL TERMINAL CONNECTORS. THE CLEAR MEDICAL ADHESIVE WASTORN/SEPARATED FROM THE GORE COVERING AT THE PROXIMAL END OF THE SPRING ELECTRODE. THE PROXIMAL SPRING WAS STRETCHED AT THIS POINT. THERE WAS A CUT THROUGH THE INSULATION 47 CENTIMETERS FROM THE IS-1 TERMINAL PIN WHICH WAS LIKELY DAMAGE FROM THE EXPLANT PROCEDURE. RESISTANCE AND PRESSURE TEST WERE USED TO TEST ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ELECTIVELY REPLACED. IT WAS NOTED THAT THE PATIENT WAS NOT CAPTURING AT 6.5 VOLTS AND THE PHYSICIAN PREFERS TO USE ACTIVE FIX LEADS; THEREFORE, THE PHYSICIAN OPTED TO REPLACE THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4076| E110| 7122| 0175