BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3061798 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06243
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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 AT THIS TIME, 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 THE LEAD SAFETY SWITCH ACTIVATED ON THIS RIGHT VENTRICULAR (RV) LEAD DUE TO DETECTING AN OUT OF RANGE IMPEDANCE MEASUREMENT. EVENTS THAT APPEARED TO BE NOISE WERE RECORDED IN THE ARRHYTHMIA LOGBOOK; HOWEVER, THESE EVENTS COULD NOT BE REPRODUCED WITH ISOMETRICS. NO PATIENT SYMPTOMS WERE REPORTED. THE LEAD WILL BE EVALUATED WHEN THE PULSE GENERATOR IS REPLACED WITHIN THE NEXT YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163504 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4456| 1290| 4087| 4086