BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 889201 · Received July 27, 2007

    Report

    Report Number
    2182207-2007-02452
    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 BEING TREATED FOR SPASTICITY WITH AN IMPLANTABLE INFUSION PUMP EXPERIENCED A PUMP RELATED INFECTION 114 DAYS POST PUMP IMPLANT. THE PT PRESENTED WITH FEVER, SWELLING, DEHISCENCE AND ERYTHEMA WERE NOTED AT PUMP SURGERY SITE. ADD'L FINDINGS DURING DEVICE EXPLANT SURGERY INCLUDED OTHER INFECTION AND POCKET ERYTHEMA. OTHER SURGICAL PROCEDURE BEYOND THE REMOVAL OF THE DEVICE WERE THE REVISION OF THE LUMBAR WOUND AND REVISION OF A DRAINING ULCER. 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 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 20 YR Hospitalization| R CATHETER| PROGRAMMER