BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 889197 · Received July 27, 2007

    Report

    Report Number
    2182207-2007-02447
    Event Type
    Injury
    Date Received
    July 27, 2007
    Report Date
    June 11, 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 MALE PT BEING TREATED FOR SPASTICITY WITH AN IMPLANTABLE INFUSION PUMP EXPERIENCED A PUMP RELATED INFECTION (GRAM-NEGATIVE MENINGITIS). FOUR DAYS POST PUMP REPLACEMENT DUE TO BATTERY DEPLETION, THE PT PRESENTED WITH FEVER, SWELLING AT THE PUMP POCKET SITE DECREASED ENERGY AND INCREASED SPASTICITY WITH HYPOTENSION AND TACHYCARDIA. E. COLI WAS IDENTIFIED IN BOTH THE PUMP AND CSF. PT WAS TREATED WITH ANTIBIOTICS AND PLACED ON VENTILATOR SUPPORT. OTHER COMPLICATIONS DURING TREATMENT INCLUDED COAGULOPATHY, THROMBOCYTOPENIA, HEADACHE, WEAKNESS AND WEIGHT LOSS. AFTER 28 DAYS, THE PT HAD RETURNED TO HIS PREVIOUS STATUS. THE PUMP WAS EXPLANTED. 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 18 YR Hospitalization| R CATHETER| PROGRAMMER