BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED

    MDR report key: 886493 · Received July 27, 2007

    Report

    Report Number
    2182207-2007-02451
    Event Type
    Death
    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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE ARTICLE LISTS INFO SUGGESTING A MALE PT BEING TREATED FOR SPASTICITY WITH AN IMPLANTABLE INFUSION PUMP EXPERIENCED A PUMP RELATED INFECTION 110 DAYS POST PUMP IMPLANT. THE PT PRESENTED WITH DEHISCENCE, EROSION ( EXPOSED HARDWARE) AND DRAINAGE AT PUMP SURGERY SITE ALONG WITH FEVER AND OTHER (UNSPECIFIED) INFECTION. SYMPTOMS INCLUDED INCREASED SPASTICITY; THE PUMP WAS EXPLANTED. THE PT EXPIRED. JOURNAL REFERENCE: WUNDERLICH, C. ET AL. "GRAM-NEGATIVE MENINGITIS AND INFECTIONS IN INDIVIDUALS TREATED WITH INTRATHECAL BACLOFEN OF SPASTICITY: A RETROSPECTIVE STUDY." DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY. 2006; 48: 450-455.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death CATHETER| PROGRAMMER