BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3241416 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-11699
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE RIGHT ATRIAL (RA) IMPEDANCE MEASUREMENTS WITH THIS SYSTEM HAD BEEN TRENDING UPWARD SINCE IMPLANT. THE PHYSICIAN INITIALLY SUSPECTED A RA LEAD ANOMALY AND PERFORMED SURGICAL INTERVENTION. DURING THE REVISION, THE PHYSICIAN SUSPECTED A SETSCREW ANOMALY AND EXPLANTED THE DEVICE WHILE LEAVING THE CHRONIC LEAD UNCHANGED. THE FOLLOWING DAY, HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE AGAIN OBSERVED SO THE PHYSICIAN ELECTED TO AGAIN SURGICALLY INTERVENE, AS IT WAS NOW SUSPECTED THAT THE RA LEAD LIKELY HAD SUSTAINED A FRACTURE. DURING THE REVISION PROCEDURE, THE LEAD WAS SURGICALLY ABANDONED. A NEW ATRIAL LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340605 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R