BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3913531 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12146
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    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 DISLODGED RESULTING IN UNDERSENSING OF THE PATIENT¿S P-WAVE. THE LEAD WAS REPOSITIONED. FOLLOWING THE PROCEDURE THE LEAD EXHIBITED LOW AMPLITUDE. ALTHOUGH THE LEAD REMAINS IN SERVICE IT HAS BEEN ELECTRICALLY DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391486 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4480| P142| 4555| 0695