BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 889195 · Received July 27, 2007

    Report

    Report Number
    2182207-2007-02457
    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 FEMALE PT BEING TREATED FOR SPASTICITY WITH AN IMPLANTABLE INFUSION PUMP EXPERIENCED A PUMP RELATED INFECTION (GRAM-NEGATIVE MENINGITIS). THREE DAYS POST ROUTINE PUMP REPLACEMENT SECONDARY TO CATHETER DISCONNECT, THE PT PRESENTED WITH FEVER, NECK PAIN, STIFFNESS, HEADACHE, NAUSEA AND VOMITING. SHE WAS NOTED TO HAVE DRAINAGE FROM HER BACK INCISION. PUMP POCKET CULTURES GREW E. COLI THAT WAS RESISTANT TO AMPICILLIN. PT WAS TREATED WITH ANTIBIOTICS. OTHER COMPLICATIONS DURING TREATMENT INCLUDED; FOCAL SEIZURE, COAGULOPATHY, MILD UPPER GASTROINTESTINAL BLEED, NEW CRANIAL NERVE PALSY RESULTING IN DYSPHAGIA AND A HERPETIC RASH. FOLLOWING 23 DAYS OF HOSPITALIZATION, SHE WAS NOTED AS HAVING DECREASE IN AMBULATION SECONDARY TO INCREASE IN SPASTICITY, DECREASE IN ACTIVITIES OF DAILY LIVING DUE TO NERVE PALSY AND DECREASE IN ORAL MOTOR STRENGTH. SHE ALSO NEEDED PSYCHOLOGICAL SUPPORT SECONDARY TO HER DEPRESSIVE DISORDER AND ADJUSTMENT AFTER HER HOSPITALIZATION. HER NERVE PALSY WAS RESOLVED AND SPASTICITY IS BEING MANAGED WITH PERIODIC BTX-A INJECTIONS. 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 22 YR Hospitalization| R PROGRAMMER| CATHETHER