BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043287 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02226
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD 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 DECREASED P WAVE SENSING, DECREASED IMPEDANCES, AND HIGH PACING THRESHOLDS WERE NOTED ON THIS RIGHT ATRIAL LEAD. A LEAD DISLODGMENT WAS CONFIRMED VIA X-RAY AND WAS SUSPECTED AS THE CAUSE OF THE DIAGNOSTICS ISSUE. THE LEAD WAS EXPLANTED AND REPLACED WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147303 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R