BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3053618 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05295
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 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

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WS SUCCESSFULLY REPOSITIONED. 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 ONE DAY POST IMPLANT, THIS LEAD DISPLAYED SENSING, IMPEDANCE AND THRESHOLD MEASUREMENT CHANGES. LEAD DISLODGEMENT WAS SUSPECTED. INTERROGATION REVEALED SUCCESSFUL DEVICE CAPTURE. A LEAD REVISION WAS PERFORMED. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED REPOSITIONING DUE TO THE EXPOSED HELIX AND THE LEAD BECAME SNAGGED ON THE TRICUSPID VALVE MULTIPLE TIMES. FINALLY, THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155872 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R