BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACING SYSTEM ANALYZER

    MDR report key: 8784783 · Received July 12, 2019

    Report

    Report Number
    2182208-2019-01250
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    UDI-DI
    00721902256011
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE ANALYZER WAS FOUND TO BE UNABLE TO COMMUNICATE WITH TEST EQUIPMENT AND A WORKING PROGRAMMER. THE ANALYZER WAS FORWARDED TO THE CONTRACT MANUFACTURER FOR REPAIR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE ANALYZER WAS RETURNED WITHOUT ACCOMPANYING INFORMATION, AND SUBSEQUENTLY TESTED OUT-OF-SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577529 PACING SYSTEM ANALYZER PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 229047 00721902256011

    Patients

    Seq Age Sex Outcome Treatment
    1