BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2780079 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12449
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 25, 2012
    Report Date
    September 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PACING IMPEDANCES GREATER THAN 3,000 OHMS. THERE WERE SOME INAPPROPRIATELY STORED ATRIAL EVENTS THAT APPEARS TO BE A RESULT OF NOISE. THE OUT OF RANGE IMPEDANCE MEASUREMENT WAS ABLE TO BE REPRODUCED WITH POCKET MANIPULATION; HOWEVER ALL OTHER IMPEDANCE MEASUREMENTS WERE IN THE 300'S OHMS RANGE. THE ATRIAL SENSITIVITY WAS DECREASED AND IT WAS REPORTED THAT THIS PATIENT WOULD MANAGED NON-INVASIVELY AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 71 YR T165| 4469| 0184| MISMATCH