BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1202830 · Received October 17, 2008

    Report

    Report Number
    2182207-2008-06645
    Event Type
    Injury
    Date Received
    October 17, 2008
    Report Date
    September 16, 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

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: KHERA J, GHOSH D, LUCIANO M. A STUDY OF INTRATHECAL BACLOFEN PUMPS IN CHILDREN: EXPERIENCE FROM A TERTIARY CARE CENTER. NEUROLOGY. 2008;70 (11, SUPPL.1):A131. TO DETERMINE INDICATIONS, UTILITY, AND COMPLICATIONS OF INTRATHECAL BACLOFEN (TB) PUMP THERAPY IN CHILDREN. SINGLE CENTER, RETROSPECTIVE REVIEW AFTER IRB APPROVAL. INCLUSION CRITERIA: PTS < 21 YEARS WITH ITB PUMP PLACED BETWEEN 1996-2006. EIGHTY FIVE PTS IDENTIFIED WITH ITB FOR SPASTICITY AND DYSTONIA HAD FOLLOW-UP FOR AN AVERAGE OF 38 MOS. MFR OF PUMP AND CATHETER WAS NOT STATED. REPORTABLE EVENT: 29 PTS HAD COMPLICATIONS NECESSITATING REVISION OR PUMP REMOVAL ONLY. SEE MFG REPORT 2182207200806629.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL UNK N=1| CATHETER MODEL UNK N=1