BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3210035 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07245
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    November 1, 2012
    Report Date
    April 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DURING A ROUTINE DEVICE INTERROGATION THE FIELD REPRESENTATIVE NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INCREASED THRESHOLD MEASUREMENTS WITH LOSS OF CAPTURE AND A LARGE CHANGE IN THE IMPEDANCE MEASUREMENT FROM 500 OHMS AT THE PREVIOUS CHECK THREE MONTHS EARLIER TO 1479 OHMS. NO NOISE WAS OBSERVED. REVIEW OF THE PATIENT'S DATA REVEALED THAT THERE WERE SPIKES IN THE IMPEDANCE MEASUREMENTS THROUGHOUT THE LAST FEW MONTHS AND A CHANGE FROM 1900 OHMS FIVE MONTHS AGO TO 400 OHMS FOUR MONTHS EARLIER. THE FIELD REPRESENTATIVE REPROGRAMMED THE OUTPUT TO 4.5 VOLTS AT 0.5, WHICH RESTORED CAPTURE. A FRACTURE WAS SUSPECTED. SINCE THE PATIENT WAS A SNOW BIRD AND LEAVING FOR THEIR NORTHERN HOME A COUPLE DAYS AFTER THE DEVICE CHECK, THEY WERE INSTRUCTED TO FOLLOW-UP WITH THEIR OTHER FOLLOWING PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310097 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4513| 1861| 4470| H135| N118| 0158| H175