BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 1610786 · Received February 3, 2010

    Report

    Report Number
    3007566237-2010-00784
    Event Type
    Malfunction
    Date Received
    February 3, 2010
    Date of Event
    November 23, 2009
    Report Date
    January 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    LITERATURE: ANONYMOUS. PROCEEDINGS OF THE 154TH MEETING OF THE SOCIETY OF THE BRITISH NEUROLOGICAL SURGEONS: DUBLIN, IRELAND, OCTOBER 2009. BR J NEUROSURG. 2009; 23(5): 468-490. KHAN, A.A., BIRKS-AGNEY, I., MCGILLOWAY, E., BULLOCK, P. & RUHTON, D. (2009). LONG TERM OUTCOME OF INTRATHECAL BACLOFEN PUMP IMPLANTATION IN PATIENTS WITH ADVANCED MULTIPLE SCLEROSIS [ABSTRACT]. SUMMARY: THE AIM OF THIS STUDY WAS TO REVIEW THE LONG TERM OUTCOME IN A GROUP OF 40 SEVERELY DISABLED PATIENTS WITH MULTIPLE SCLEROSIS WHO UNDERWENT INTRATHECAL BACLOFEN (ITB) PUMP IMPLANT AND TREATMENT BETWEEN 1996 AND 2007. REPORTABLE EVENT: FOUR PATIENTS EXPERIENCED CATHETER MIGRATION. NO PATIENT SYMPTOMS, TREATMENT, OR OUTCOME WAS REPORTED. SEE LITERATURE REPORT WITH MFR REPORT # 3007566237-2010-00780.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| PROGRAMMER: MODEL: UNKNOWN, LOT # UNKNOWN| CATHETER: MODEL UNKNOWN, LOT # UNKNOWN| IMPLANTED: