BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3213626 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09377
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PHYSICIAN

    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 THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED AND EXHIBITED FAR-FIELD R-WAVE OVERSENSING (FFRWOS) AND LOSS OF CAPTURE. THE PHYSICIAN WAS CONCERNED WITH SOME EXTRA SIGNALS ON THE LEAD. ADDITIONAL INFORMATION RECEIVED AND CONFIRMED BY FIELD REPRESENTATIVE THAT THIS RA LEAD HAD EXPERIENCED MICRO DISLODGEMENT AND REPOSITIONED WAS ALREADY DONE. FURTHERMORE, NO OTHER ISSUES REPORTED AS MEASUREMENTS WERE GOOD. THIS RA LEAD WAS REPOSITIONED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312620 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4479| K063| 4459