BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE INFUSION PUMP

    MDR report key: 3201674 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00096
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    January 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP HAD BEEN EMPTY FOR THE PAST 30 DAYS. NO ADDITIONAL INFORMATION WAS RECIEVED. THE DRUG IN THE PUMP WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301632 UNKNOWN IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1