BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 889206 · Received July 27, 2007

    Report

    Report Number
    2182207-2007-02445
    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

    THIS REPORT REPRESENTS THE 33 INFECTIONS NOT CONSIDERED GRAM-NEGATIVE. DETAILED PT INFO WAS PROVIDED ON 12 PATIENTS WITH GRAM-POSITIVE INFECTIONS AND THOSE EVENTS HAVE BEEN SUBMITTED ON SEPARATE MDR REPORTS.

    Description of Event or Problem · 1

    THE ARTICLE LISTS INFO SUGGESTING 33 PUMP RELATED INFECTIONS OCCURRED IN THE STUDY GROUP THAT WERE NOT FOUND TO BE GRAM-NEGATIVE INFECTIONS (N=12). NO ADD'L PT SPECIFIC INFO CONCERNING THE DEVICE STATUS, 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 YR Hospitalization| R PROGRAMMER| CATHETER