BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3211556 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08918
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 11, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. A FIELD REPRESENTATIVE REVIEWED THE HOSPITAL CHART FOR THIS PATIENT AND LEAD AND LEARNED THAT THE LEAD WAS REPOSITIONED THE FOLLOWING DAY. THE LEAD REMAINS IN SERVICE. 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

    AS OF TODAY, THE LEAD REMAINS IMPLANTED BUT ABANDONED ELECTRICALLY. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE POST-OPERATIVE DEVICE CHECK, LOSS OF ATRIAL CAPTURE WAS OBSERVED. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE DEVICE WAS REPROGRAMMED FOR RIGHT VENTRICULAR PACING AND THE IMPLANTING PHYSICIAN WAS INFORMED. NO LEAD REVISION WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311409 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R