BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXION PERMANENT PACING LEAD

    MDR report key: 5518043 · Received March 22, 2016

    Report

    Report Number
    1035166-2016-00035
    Event Type
    Injury
    Date Received
    March 22, 2016
    Date of Event
    February 10, 2016
    Report Date
    March 4, 2016
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K964107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS IN USE FOR TREATMENT. THE LEAD REMAINED ACTIVELY IMPLANTED FOR APPROXIMATELY 14 YEARS, 8 MONTHS. THE LEAD WAS TAKEN OUT OF SERVICE AND WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THE LEAD (NOISE) CANNOT BE CONFIRMED. PACING LEAD NOISE IS A KNOWN CLINICAL EVENT REFERENCED IN THE MEDICAL LITERATURE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT, C2-01207 FOUND NO REJECTS DURING MANUFACTURE OF THIS LOT. A REVIEW OF COMPLAINTS AGAINST THIS LOT NUMBER, C2-01207 IDENTIFIED ONE (1) OTHER COMPLAINT WHERE THERE WAS A REPORT OF NO P-WAVE MEASUREMENTS.

    Description of Event or Problem · 1

    THIS ATRIAL LEAD WAS EXHIBITING NOISE AND WAS SURGICALLY ABANDONED AT THE SAME TIME THE RIGHT VENTRICULAR LEAD WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174671 FLEXION PERMANENT PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. 4016 C2-01207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention