BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3913520 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-09292
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    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

    (B)(4). 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 HAD BEEN DISLODGED. BOSTON SCIENTIFIC COMPANY REPRESENTATIVE REPORTED THAT THE RA LEAD HAD ATRIAL PACING FAILURE DUE TO THE RA LEAD DISLODGEMENT. THE LEAD DISLODGEMENT WAS CONFIRMED BY X-RAY. A REVISION PROCEDURE WAS PERFORMED THE FOLLOWING DAY. THE LEAD WAS ATTEMPTED TO BE REPOSITIONED BUT WAS UNSUCCESSFUL DUE TO AN ENLARGED HEART. THE RA LEAD WAS EXPLANTED AS A NEW LEAD WAS IMPLANTED. THE RA LEAD WAS OUT OF SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391838 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4456| J177| 4479