BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2911718 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16300
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND RIGHT ATRIAL (RA) LEAD REMAIN IN SERVICE AT THIS TIME. A X-RAY OF THE LEADS AND DEVICE HEADER WILL BE PERFORMED IN THE FUTURE TO DETERMINE FURTHER ACTION. ONCE INFORMATION IS RECEIVED OF THE X-RAY A FINAL REPORT WILL BE SUBMITTED. SHOULD THE DEVICE BE RETURNED TO BOSTON SCIENTIFIC THE DEVICE AND LEAD WILL UNDERGO DETAILED LABORATORY ANALYSIS TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS DEVICE AND RIGHT ATRIAL (RA) LEAD HAD TRIGGERED A LEAD SAFETY SWITCH WHICH OCCURED DUE TO OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. THRESHOLD TEST COULD NOT BE PERFORMED DUE TO PATIENT'S HIGH RATE OF 120 BEATS PER MINUTE (BPM). THE PHYSICIAN SUSPECTED A SETSCREW OR HEADER ISSUE; THEREFORE, DECIDED TO REPROGRAM THE DEVICE. A X-RAY OF THE LEADS AND DEVICE HEADER WILL BE PERFORMED IN THE FUTURE TO DETERMINE FURTHER ACTION. THE DEVICE AND RIGHT ATRIAL (RA) LEAD REMAIN IN SERVICE AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18460 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1