BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PUMP

    MDR report key: 3910647 · Received July 2, 2014

    Report

    Report Number
    3007566237-2014-01859
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD DEVELOPED EPILEPTIC SEIZURES. THE PUMP WAS USED TO DELIVER BACLOFEN. PATIENT OUTCOME WAS NOT PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387744 UNKNOWN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Other