BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 889200 · Received July 27, 2007

    Report

    Report Number
    2182207-2007-02458
    Event Type
    Injury
    Date Received
    July 27, 2007
    Report Date
    May 9, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ARTICLE LISTS INFO SUGGESTING A FEMALE PT BEING TREATED FOR SPASTICITY WITH AN IMPLANTABLE INFUSION PUMP EXPERIENCED A DEVICE RELATED INFECTION 14 DAYS POST IMPLANT. THE PT PRESENTED WITH DEHISCENCE, ERYTHEMA, OTHER INFECTION (UNSPECIFIED), INCREASED SPASTICITY AND A CEREBRAL SPINAL FLUID LEAK. ADD'L SURGICAL PROCEDURES INCLUDED A CATHETER REVISION AND REPAIR OF THE DURAL LEAK. THE PT WAS TREATED WITH ANTIBIOTICS AND THE PUMP REMAINED IMPLANTED FOR NINE MONTHS BUT WAS SUBSEQUENTLY EXPLANTED. POST DURAL REPAIR PROCEDURE COMPLICATIONS INCLUDED A LOW GRADE FEVER AND INCREASED SPASTICITY. NO ADD'L INFO CONCERNING PT SYMPTOMS AND OUTCOME WAS PROVIDED. JOURNAL REFERENCE: WUNDERLICH, C. ET AL. "GRAM-NEGATIVE MENINGITIS AND INFECTIONS IN INDIVIDUALS TREATED WITH INTRATHECAL BACLOFEN FOR SPASTICITY: A STUDY." DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY. 2006; 48: 450-455.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R IMPLANTABLE INFUSION PUMP| PROGRAMMER