BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153146 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06185
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING PRODUCT RETURN AND COMPLETION OF LABORATORY ANALYSIS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RETURN, THIS LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION CONFIRMED A COMPLETE LEAD WITH SET SCREW MARKS NOTED ON THE TERMINAL PIN. INSULATION ON THE RATE/SENSE COIL WAS NOTED WRINKLED SPORADICALLY BETWEEN 22 CM TO 32 CM FROM THE PIN. THE HELIX WAS RETRACTED WITH NOTABLE DRIED BLOOD; HOWEVER, PHYSICALLY WITHIN SPECIFICATIONS. EXTENSIVE TESTING WAS THEN 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. LABORATORY ANALYSIS WAS UNABLE TO VERIFY THE REPORTED CLINICAL OBSERVATIONS OF THIS CASE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE FIRST OUTPATIENT FOLLOW-UP POST RIGHT VENTRICULAR LEAD IMPLANT, HIGH PACING THRESHOLDS AND LOSS OF CAPTURE WERE EXHIBITED. AN X-RAY WAS PERFORMED AT WHICH TIME THE LEAD WAS CONFIRMED DISLODGED. LEAD REPOSITIONING WAS SCHEDULED; HOWEVER, DUE TO PATIENT ANATOMY TO INCLUDE A SMALL SUBCLAVIAN VEIN, THE LEAD WAS NOT SUCCESSFULLY REPOSITIONED AND CONSEQUENTLY REMOVED. THE EXPLANTED PRODUCT IS INTENDED TO BE RETURNED FOR A POST MARKET ASSESSMENT AND NO FURTHER ADVERSE PATIENT EFFECTS REPORTED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention