BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3153253 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01403
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5071, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DOUBLE COUNTING OF P WAVES ON THE RIGHT ATRIAL (RA) LEAD, AND THERE WAS MODE SWITCHING AS A RESULT. IT WAS NOTED THAT THE PATIENT HAS HAD A HEART TRANSPLANT AND IT IS BELIEVED THAT THE DOUBLE COUNTING OF P WAVES HAS TO DO WITH PARTS OF THE DONOR¿S HEART BEING USED DURING THE PROCEDURE. IT IS BELIEVED THAT BOTH SINOATRIAL (SA) NODES WOULD BE FIRING AT THE SAME TIME, HOWEVER, REPROGRAMMING WAS DONE TO MASK WHICHEVER SA NODE WAS NOT NEEDED FOR THE PATIENT'S WELL BEING. THE LEAD IS STILL 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
    255114 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)