BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 889279 · Received July 27, 2007

    Report

    Report Number
    2182207-2007-02456
    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

    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 55 DAYS POST PUMP IMPLANT. THE PT PRESENTED WITH DEHISCENCE, DRAINAGE AND EXUDATE AT PUMP SURGERY SITE ALONG WITH INCREASED SPASTICITY AND OTHER (UNSPECIFIED) INFECTION. ADD'L FINDINGS DURING EXPLANT SURGERY INCLUDED A DRAINING ULCER. NO ADD'L INFO CONCERNING PT SYMPTOMS AND OUTCOME WERE PROVIDED. JOURNAL REFERENCE: WUNDERLICH, C. ET AL. "GRAM-NEGATIVE MENINGITIS AND INFECTIONS IN INDIVIDUALS TREATED WITH INTRATHECAL BACLOFEN FOR 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 22 YR Hospitalization| R PROGRAMMER MODEL PROGRAMMER LOT #UNK| EXPLANTED| IMPLANTED| CATHETER MODEL LOT #UNK| IMPLANTED| EXPLANTED