BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3210970 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07757
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 30, 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

    A LEAD REVISION WAS PERFORMED. THIS RA LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED WITH RA PACING PROGRAMMED OFF, PENDING A REVISION PROCEDURE. THIS INVESTIGATION WILL BE UPDATED WHEN FURTHER INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED INCREASED PACING THRESHOLD MEASUREMENTS. AN X-RAY WAS PERFORMED, WHICH REVEALED THE LEAD HAD DISLODGED. THE DEVICE WAS REPROGRAMMED UNTIL A REVISION PROCEDURE COULD BE PERFORMED AT THE END OF MAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310513 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R