BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3050014 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03972
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A MODE SWITCH DUE TO A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. NOISE WAS ALSO NOTED. THE PATIENT IS NOT PACEMAKER DEPENDENT AND HAD NO SYMPTOMS. THE PHYSICIAN PLANS TO MONITOR THE PATIENT FOR NOW AS THE PATIENT HAS OTHER ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152651 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 4471| 4470| S603