BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3211307 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08981
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 PATIENT HAD NOT BEEN SEEN IN THE CLINIC SINCE THE END OF 2008. AT A FOLLOW-UP APPOINTMENT IT OBSERVED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS HAD INCREASED THRESHOLDS AND INTERMITTENT LOSS OF CAPTURE. IT WAS ALSO NOTED THAT THE LEAD IMPEDANCES WERE BETWEEN 200 TO 900 OHMS AND, AT THE TIME OF THE CHECK, WERE 1010 OHMS. THE PATIENT HAD AN ESCAPE RHYTHM IN THE 30S, AND WAS TIRED; HOWEVER, NO PAUSES GREATER THAN TWO SECONDS WERE NOTED. SURGICAL INTERVENTION WAS PERFORMED WHERE THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED, AND THE PACEMAKER GENERATOR WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311447 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Congenital Anomaly| H| L 4457| S603| 4480| 4136