BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1952287 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23718
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PULSE GENERATOR AND LEAD PRESENTED TO THE CLINIC WITH NO OUTPUT FROM THE DEVICE. ELECTIVE REPLACEMENT INDICATOR (ERI) HAD BEEN DECLARED ONE DAY PRIOR. THERE WAS NO CAPTURE AT MAXIMUM OUTPUTS AND THE DEVICE WOULD NOT PACE WHEN A MAGNET WAS APPLIED. A RECENT TRANSTELEPHONIC MONITORING REVEALED NORMAL DEVICE OPERATION AND A MAGNET RATE OF 90 BEATS PER MINUTE. THE PATIENT HAS HAD SOME LONG PAUSES BUT WAS ASYMPTOMATIC. TECHNICAL SERVICES DISCUSSED THAT THERE WAS A POTENTIAL DEVICE AND/OR LEAD MALFUNCTION. DEVICE REPLACEMENT WAS PLANNED FOR THE FOLLOWING DAY. ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)