BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPX101

    MDR report key: 2791289 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14822
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 6, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE RIGHT ATRIAL (RA) LEAD WAS ATTEMPTED TO BE PLACED SEVERAL TIMES AND EACH TIME IT WAS NOT POSSIBLE TO ADVANCE THE ATRIAL LEAD INTO THE ATRIUM. WHEN A STYLET WAS PUT INTO THE RA LEAD, THE LEAD DID NOT CURVE INTO A J-SHAPE. THREE DIFFERENT STYLET TYPES THAT WERE PACKAGED WITH THE LEAD WERE TRIED AND NONE OF THEM WERE ABLE TO MAKE THE RA LEAD INTO A J-FORM IN THE ATRIUM. A BEND WAS MADE IN THE LEAD, BUT IT WAS TOO HIGH IN THE ATRIUM AND NOT A J-FORM. THE LEAD WAS SCREWED INTO THE ATRIAL WALL WITH ENOUGH SLACK BUT WITHOUT THE TYPICAL J-SHAPE IN THE ATRIAL. IT WAS NOTED THAT PACING AND SENSING THRESHOLDS WERE ON THE HIGH SIDE OF NORMAL. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NPX101 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. NPX101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other