BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910276 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15394
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 8, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS FOUND TO HAVE A GORE SEPARATION AT THE PROXIMAL END OF THE SPRING ELECTRODE AND THE PROXIMAL SPRING STRETCHED AT THIS POINT. THE HIGH THRESHOLD ALLEGATION COULD NOT BE CONFIRMED THROUGH TESTING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO PACING THRESHOLD ISSUES. THE LEAD HAD THRESHOLD READINGS OF 4.0 VOLTS AT 0.5 MILLISECONDS DURING A ROUTINE PATIENT FOLLOW-UP. A REPLACEMENT RV LEAD WAS IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16829 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 0184| 4470| E110