BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 957388 · Received December 3, 2007

    Report

    Report Number
    2182207-2007-04224
    Event Type
    Injury
    Date Received
    December 3, 2007
    Date of Event
    May 25, 2006
    Report Date
    November 12, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REPORT: HANSEN, MD., ET AL. "PROLONGED, SEVERE INTRATHECAL BACLOFEN WITHDRAWAL SYNDROME: A CASE REPORT." ARCH PHYS MED REHABILITATION. 2007; VOL 88: 1468-1471. SEE ALSO ATTACHED CIOMS REPORT. [SEE SCANNED PAGES.]

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LITERATURE REPORT THAT, THE PATIENT PRESENTED WITH WORSENING SPASTICITY AND MORE FREQUENT SPELLS OF AGITATION AND POSTURING DESPITE INCREASING DOSES IN SIMPLE CONTINUOUS INTRATHECAL BACLOFEN DOSING. THE PUMP WAS REPLACED, AS WELL AS, THE PUMP PORTION OF A 2 PIECE CATHETER. THE SPINAL PORTION OF THE CATHETER WAS LEFT IN PLACE AS THE CEREBROSPINAL FLUID BACKFLOW WAS STRONG. HER SYMPTOMS DID NOT IMPROVE. PLAIN FILMS DID NOT REVEAL DISCONTINUITY OF THE SYSTEM; AFTER 3 WEEKS, THE PUMP WAS AGAIN REPLACED. PLEASE REFER TO MANUFACTURER'S REPORT #: 2182207-2006-01055 FOR THE REPORT ON THIS DEVICE. ALSO, PLEASE REFER TO MANUFACTURER'S REPORT #S" 2182207-2006-01055, 2182207-2007-04225, 6000030-2007-04226 AND 6000030-2007-04227 AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK MEDTRONIC NEUROMODULATION 8626 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R EXPLANTED| IMPLANTED| EXPLANTED| CATHETER MODEL 8711| PROGRAMMER MODEL PROGRAMMER