BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEU_UNKNOWN_PUMP

    MDR report key: 3202391 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00956
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    April 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP ALARM WENT OFF. IT WAS NOTED THAT ¿THE PUMP SHUT OFF¿ POSSIBLY DUE TO INTERFERENCE FROM ¿MAGNET OR SOMETHING IN THE OPERATING ROOM.¿ THE PATIENT OUTCOME WAS UNKNOWN. THE DRUG USED IN THE PUMP WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303037 NEU_UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1