BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3040786 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-04432
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. CLINIC EVALUATION WAS PERFORMED AND WHEN THE PATIENT SAT STILL NORMAL LEAD MEASUREMENTS WERE OBTAINED. HOWEVER, WITH RANGE OF MOTION AND ARMS ABOVE HEAD, THE LEAD IMPEDANCE WAS CONSISTENTLY > 2000 OHMS AND SOME NOISE WAS NOTED. THRESHOLD AND SENSING TESTS WERE NOT PERFORMED WHEN THE PATIENT'S ARMS WERE ABOVE THE HEAD. THE DEVICE WAS REPROGRAMMED TO DDI 40 TO MINIMIZE PACING AND THE PATIENT WAS ADVISED TO TRY TO KEEP HER ARMS BELOW HER HEAD. THE PLAN IS TO MONITOR AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE LEAD REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. CLINIC EVALUATION WAS PERFORMED AND WHEN THE PATIENT SAT STILL NORMAL LEAD MEASUREMENTS WERE OBTAINED. HOWEVER, WITH RANGE OF MOTION AND ARMS ABOVE HEAD, THE LEAD IMPEDANCE WAS CONSISTENTLY > 2000 OHMS AND SOME NOISE WAS NOTED. THRESHOLD AND SENSING TESTS WERE NOT PERFORMED WHEN THE PATIENT'S ARMS WERE ABOVE THE HEAD. THE DEVICE WAS REPROGRAMMED TO DDI 40 TO MINIMIZE PACING AND THE PATIENT WAS ADVISED TO TRY TO KEEP HER ARMS BELOW HER HEAD. THE PLAN IS TO MONITOR AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143144 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 4469| 0147| E110| 1861