BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041239 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02470
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 HIGH PACING IMPEDANCES WERE DETECTED ON THIS RIGHT VENTRICULAR LEAD VIA THE LATITUDE PATIENT MONITORING SYSTEM. AT A RECENT FOLLOW UP, THE ROOT CAUSE WAS DETERMINED TO BE A LEAD DISLODGEMENT RESULTING IN THE HIGH IMPEDANCES ALONG WITH HIGH PACING THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD SUCCESSFULLY WITH NORMAL DIAGNOSTICS NOTED AFTER THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142581 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4096| F142| 0295