BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2913743 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00137
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE POST IMPLANT. THE PATIENT WAS EVALUATED AND THRESHOLDS WERE FINE. THE PATIENT WAS REPORTED TO BE PACER DEPENDENT. IT WAS REPORTED THAT THE LOSS OF CAPTURE RESULTED IN A COUPLE DROPPED BEATS; HOWEVER, NO ASYSTOLE GREATER THAN TWO SECONDS. LOSS OF CAPTURE WAS AGAIN EXHIBITED THE MORNING AFTER IMPLANT. IT WAS BELIEVED THAT THIS PRODUCT EXHIBITED MICRODISLODGEMENT AND THE THRESHOLDS WERE REPROGRAMMED TO 5 VOLTS AT 1 MILLISECOND. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21093 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR K173| 4457| 4470