BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAYAMED

    MDR report key: 2951842 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00276
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 15, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED ANALYZED, AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE DISTAL END OF THE CONDUCTOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS NO RWAVE SENSING OBSERVED. ALSO, THE LEAD'S HELIX WOULD NOT EXTEND. THE LEAD WAS NOT USED, AND A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57746 NAYAMED ELECTRODE, PACEMAKER, PERMANENT DTB MPRI NPX10158

    Patients

    Seq Age Sex Outcome Treatment
    1