BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040675 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00662
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DAY, THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. IT WAS NOTED THE DEVICE WAS ALSO REPLACED DURING THE PROCEDURE. AS THE LEAD WAS NOT ABLE TO BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD RECEIVED THREE INAPPROPRIATE SHOCKS. THE PATIENT PRESENTED TO THE HOSPITAL, WHERE AN X-RAY CONFIRMED THE RV LEAD WAS FRACTURED. THE DEVICE WAS PROGRAMMED TO MONITOR ONLY AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. A REVIEW OF DEVICE DATA SHOWED THE RV PACING IMPEDANCE MEASUREMENTS HAD BEEN DECREASING FIVE DAYS PRIOR TO THE SHOCK DELIVERY; ON THE DATE THE SHOCKS WERE DELIVERED, THE RV PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS. THE SHOCKS WERE DUE TO NOISE THAT WAS OVERSENSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143622 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R