BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140408 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17463
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RETURN, THIS LEAD WAS THOROUGHLY ANALYZED. VISUAL EXAMINATION REVEALED A COMPLETE LEAD, NO BREACHES IN LEAD'S INSULATION AND CONFIRMED SETSCREW MARKS ON THE TERMINAL PIN. EXTENSIVE TESTING WAS PERFORMED TO ASSESS THE LEAD'S ELECTRICAL AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY AND THE LEAD INSULATION. RIGOROUS TESTING, INCLUDING EXTENSIVE LEAD MANIPULATION WHILE CONNECTED TO AN OHMMETER, VERIFIED THERE WAS NO INTERMITTENCY IN THE ELECTRICAL CONDUCTIVITY. ANALYSIS CONCLUDED THAT THE LEAD WAS ELECTRICALLY CONTINUOUS AND DID NOT IDENTIFY ANY MANUFACTURING ANOMALIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED FIELD ANOMALY. THE LEAD HAS BEEN ARCHIVED AS MEETING SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ATTEMPTED IMPLANT, HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE EXHIBITED WITH THIS RIGHT VENTRICULAR LEAD. THE PHYSICIAN WAS UNABLE TO RESOLVE THE ISSUE AND EXPLANTED THE LEAD IN FAVOR OF A DUAL-COIL LEAD MODEL. THE ATTEMPTED IMPLANT LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618686 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR D010| 0296| 0293