BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203568 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-01135
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    July 27, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CATHETER MIGRATION/DISLODGEMENT WAS REPORTED. THE REPORTER SAID IT HAD HAPPENED TO ANOTHER PATIENT, BUT "HE TOOK A PRETTY GOOD SHOT TO GET IT KNOCKED LOOSE". THE DRUG(S) USED IN THE DEVICE WERE NOT REPORTED. 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
    304149 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1