BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3980369 · Received August 5, 2014

    Report

    Report Number
    3007566237-2014-02181
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PUMP THAT WAS INFECTED. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THE EVENT WAS NOT PROVIDED HOWEVER HYDROMORPHONE WAS LISTED AS AN OLD MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456819 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention