BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3202897 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01077
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAD A NUMBER OF MOTOR STALLS WITH RECOVERIES. EACH MOTOR STALL WAS FROM 20 TO 90 MINUTES IN DURATION. IT WAS REPORTED THAT MOTOR STALLS MAY BE CAUSED BY ELECTROMAGNETIC INTERFERENCE, BUT THIS WAS NOT CONFIRMED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302748 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1