BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1051464 · Received May 21, 2008

    Report

    Report Number
    6000030-2008-02687
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED HYPERTONIA AFTER RECENT PUMP AND CATHETER REPLACEMENT. THE CATHETER WAS REVISED; NO ADD'L INFO WAS PROVIDED. THE PT HAD NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8709 N129865006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| PROGRAMMER MODEL 8840| PUMP MODEL # 863720| EXPLANTED