BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3905565 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11863
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS RETAINED BY THE HOSPITAL. 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 EXPLANTED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. IT WAS REPORTED THE PRODUCT PERFORMANCE ISSUE WAS NOTICED DURING ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD EXTRACTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383857 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 1581| V-197| 3400| MISMATCH| T165| 1010| 4470