BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 1028954 · Received April 11, 2008

    Report

    Report Number
    2182207-2008-01937
    Event Type
    Other
    Date Received
    April 11, 2008
    Report Date
    March 10, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF MEDTRONIC IS THE DEVICE MFR. A REQUEST HAS BEEN MADE TO THE AUTHOR, BUT IT REMAINS UNK.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: CAIRD, M.S., ET AL. "OUTCOMES OF POSTERIOR SPINAL FUSION AND INSTRUMENTATION IN PTS WITH CONTINUOUS INTRATHECAL BACLOFEN INFUSION PUMPS." SPINE 2008; 33(4): E94-E99. IN THIS RETROSPECTIVE STUDY, 20 SPASTIC QUADRIPLEGIC CEREBRAL PALSY (CP) PTS WITH BACLOFEN PUMPS, WHO UNDERWENT SPINAL FUSION AND INSTRUMENTATION FOR NEUROMUSCULAR SCOLIOSIS, WERE MATCHED FOR WEIGHT, AGE AND TYPE OF FUSION WITH PTS WITHOUT PUMPS. THE OBJECTIVE OF THIS STUDY IS TO DETERMINE THE RATE OF COMPLICATIONS, ADVERSE OUTCOMES, AND CURVE CORRECTION AFTER SPINAL FUSION IN PTS WITH CP AND BACLOFEN PUMPS COMPARED WITH SIMILAR PTS WITHOUT PUMPS. IT IS UNK IF THE PUMPS ARE MEDTRONIC DEVICES. A REQUEST HAS BEEN MADE TO THE AUTHOR, BUT IT REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LKK MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other