BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1032791 · Received April 23, 2008

    Report

    Report Number
    2182207-2008-02171
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS AN INCREASE IN SPASTICITY WHEN LYING DOWN, BUT THE SPASMS RESOLVE WHEN SITTING UP. THE PT HAS A CYSTIC MASS IN THE T3 REGION THAT TAKES UP THE WHOLE SPINAL CANAL. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION 8709 L71607

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTABLE INFUSION PUMP MODEL 863740| IMPLANTED| IMPLANTED