BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1850832 · Received September 28, 2010

    Report

    Report Number
    3007566237-2010-07370
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: PATEL N, ALBRIGHT L. INTRATHECAL BACLOFEN IN ADULT CEREBRAL PALSY PATIENTS. NEUROSURGERY. (B)(6). SUMMARY: THIS ABSTRACT DISCUSSES HOW THERE IS LITERATURE ABOUT THE USE OF INTRATHECAL BACLOFEN (ITB) FOR CHILDREN WITH CEREBRAL PALSY BUT LITTLE LITERATURE ABOUT ITS USE IN ADULTS WITH CP. THE OBJECTIVE OF THIS ABSTRACT WAS TO EVALUATE THE EFFECTS AND COMPLICATIONS OF ITB IN 30 ADULTS WITH CP. THIRTY CONSECUTIVE ADULT PATIENTS, RANGING IN AGE FROM (B)(6) TO (B)(6) YEARS, WITH A MEAN OF (B)(6) YEARS, WERE TREATED FOR THE FIRST TIME BY INTRATHECAL BACLOFEN PUMPS. MEAN F/U WAS 1 YEAR. MEAN UPPER EXTREMITY (B)(6) SCORES DECREASED FROM 2.7 PRE-OPERATIVELY TO 17 POSTOPERATIVELY, AND FROM 3.2 TO 1.5 IN THE LOWER EXTREMITIES. (B)(6) SCORES DECREASED FROM 18 TO 8. EVENT: TEN SURGICAL COMPLICATIONS OCCURRED: FIVE (11.6%) WOUND INFECTION (TWO OF WHICH HAD CSF LEAKS), TWO CATHETER MIGRATIONS, ONE CORD COMPRESSION, ONE PSEUDO MENINGOCELE, AND ONE WOUND BREAKDOWN WITHOUT INFECTION. OF THE FIVE INFECTIONS, FOUR PUMPS WERE REMOVED. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED.

    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 28 YR Required Intervention IMPLANT:| CATHETER: MODEL UNK, SERIAL# UNK| EXPLANT: