BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3213129 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10457
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS NOT ABLE TO BE RETURNED. 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 DURING A DEVICE REPLACEMENT PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD WAS SUCCESSFULLY REMOVED FROM THE CHRONIC, NON-BOSTON SCIENTIFIC DEVICE. THE LEAD WAS TESTED ON THE PACING SYSTEM ANALYZER (PSA) WITH GOOD MEASUREMENTS OBSERVED. WHEN THE RA LEAD WAS CONNECTED TO THE NEW NON-BOSTON SCIENTIFIC DEVICE, THE LEAD WAS FULLY INSERTED INTO THE DEVICE HEADER. WHEN THE SETSCREW ON THE NEW DEVICE WAS TIGHTENED, NO CLICKING WAS HEARD AND THE LEAD WAS NOT SECURED PROPERLY. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD, THE SETSCREW TURNED AROUND AND AROUND, WITHOUT BECOMING LOOSENED. THE DEVICE HEADER HAD TO BE BROKEN TO REMOVE THE LEAD; HOWEVER, DURING REMOVAL, THE LEAD¿S TERMINAL PIN WAS DAMAGED. THIS LEAD WAS SURGICALLY ABANDONED AND ANOTHER LEAD WAS IMPLANTED WITH A SECOND NEW DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312255 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1