BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP, UNKNOWN

    MDR report key: 3920124 · Received July 8, 2014

    Report

    Report Number
    3007566237-2014-01893
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0587-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MRI RELATED MOTOR STALL THAT RECOVERED APPROXIMATELY 4 HOURS LATER AFTER A SECOND INTERROGATION. THE PATIENT WAS ASYMPTOMATIC AND THERE WERE NO DEVICE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398164 INFUSION PUMP, UNKNOWN PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1