BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC LEAD

    MDR report key: 3993162 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02341
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SAID THAT AFTER EVERY IMPLANT, THE NEXT DAY CHECK SHOWS P/R WAVES HALF OF WHAT THEY WERE AT IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467909 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1