BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2093021 · Received May 5, 2011

    Report

    Report Number
    3007566237-2011-03243
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED VOLUME AT A "NORMAL SCHEDULED REFILL DATE". SPECIFIC VOLUME AMOUNTS WERE NOT REPORTED. ADDITIONAL INFO 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
    1 UNKNOWN UNKNOWN LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1