BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2032445 · Received March 23, 2011

    Report

    Report Number
    3007566237-2011-02246
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    April 19, 2010
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT AND EVENT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: LAGUNA DEL ESTAL P, CASTANEDA PASTOR A. LOPEZ-CANO GOMEZ M, GARCIA MONTERO P. [BACTERIAL MENINGITIS SECONDARY TO SPINAL ANALGESIA AND ANAESTHESIA]. NEUROLOGIA. NOVEMBER - DECEMBER 2010,25(9):552-556. SUMMARY: THE AUTHORS STUDIED A 485 BED UNIVERSITY HOSPITAL SERVING A POPULATION OF 600,000 RESIDENTS. THEY REVIEWED THE CHARTS OF ALL PTS OLDER THAN 14 YEARS WHO WERE DIAGNOSED WITH MENINGITIS DURING A 25-YEAR PERIOD (1982-2006) WHO WERE IMPLANTED WITH SOME KIND OF SPINAL ANALGESIC DEVICE OR HAD RECEIVED EPIDURAL ANESTHESIA DURING A SURGICAL PROCEDURE. DURING THE STUDY PERIOD, 239 CASES OF ACUTE BACTERIAL MENINGITIS (ABM) WERE DIAGNOSED; HOWEVER, ONLY 8 PTS WERE IMPLANTED WITH SPINAL ANALGESIC DEVICES OR HAD RECEIVED EPIDURAL ANESTHESIA, WHICH WAS 3.3% OF THE TOTAL OF ABM. FIVE (62.5%) CASES OF MENINGITIS WERE COMMUNITY-ACQUIRED AND 3 (37.5%) WERE NOSOCOMIAL. REPORTABLE EVENT: PT 8, A (B)(6) MALE, EXPERIENCED FEVER, HEADACHE AND NECK STIFFNESS FOR 45 DAYS FOLLOWING THE PROCEDURE FOR VERTEBRAL ANKYLOSING HYPEROSTOSIS. CEREBROSPINAL FLUID ANALYSIS REVEALED LEUKOCYTES 480/MM3, PROTEIN 168 MG/DL, GLUCOSE 60 MG/DL AND NEGATIVE GRAM STAIN. CULTURES REVEALED STAPHYLOCOCCUS EPIDERMIDIS WHICH WAS CONSIDERED TO BE COMMUNITY-ACQUIRED. THE PT WAS TREATED WITH VANCOMYCIN AND CEFTAZIDIME FOR 14 DAYS. THE PUMP AND EPIDURAL DORSAL CATHETER WERE EXPLANTED AND THE FINAL PT OUTCOME WAS REPORTED AS 'RECOVERED WITHOUT LONG-TERM EFFECTS.' SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2011-02229.

    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 62 YR Required Intervention CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED:| EXPLANTED: