BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2781061 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13345
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    November 2, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THIS PATIENT UNDERWENT A LEAD REVISION WITH REPORT OF LOSS OF CAPTURE AT MAXIMUM OUTPUTS AS WELL. DURING THE PROCEDURE, THE PHYSICIAN HAD FIRST IMPLANTED THE NEW ATRIAL LEAD. THE PHYSICIAN WAS MANEUVERING THE DEVICE, WHICH WAS IMPLANTED DEEPLY IN THE SUBPECTORAL REGION, AND HAD NOTED THAT THE HEADER WAS CONNECTED TO THE DEVICE ONLY BY THE WIRES. THE OLD ATRIAL LEAD WAS SURGICALLY ABANDONED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED.

    Additional Manufacturer Narrative · 1

    FINAL RESOLUTION HAS BEEN REQUESTED BY THE FIELD REPRESENTATIVE, HOWEVER, NOTHING FURTHER HAS BEEN RECEIVED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACING IMPEDANCES ON THIS RIGHT ATRIAL (RA) LEAD WERE GREATER THAN 2000 OHMS. NO OTHER LEAD VALUES WERE PROVIDED AND THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS TO BE FURTHER EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4469| 0148| 1861| E110