BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFIX

    MDR report key: 3992790 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09682
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PRODUCTS: 5524M45 LEAD IMPLANTED: (B)(6) 1997. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD OPEN HEART SURGERY. ON A REMOTE MONITORING TRANSMISSION AFTER THE SURGERY, THE ATRIAL AND VENTRICULAR LEADS RECORDED EPISODES OF NOISE THAT WERE SUSPECTED TO BE DUE TO CAUTERY. THE LEADS REMAIN IN USE. IT WAS ALSO REPORTED THERE WERE INDECIPHERABLE DUAL ELECTROGRAMS FOUND ON THE REMOTE PACEMAKER TRANSMISSION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470812 SUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5072-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR ADDRL1 IPG