BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1971795 · Received January 13, 2011

    Report

    Report Number
    3007566237-2011-00329
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: CARTWRIGHT JA, HOELZER BC, WUERMSER LA, BECK L,. INTRATHECAL CATHETER ASSOCIATED MASS IN A PATIENT RECEIVING BACLOFEN AS A SOLE AGENT. (B)(6). SUMMARY: INTRATHECAL CATHETER TIP LESIONS ARE A WELL KNOWN CAUSE OF FAILURE OF INTRATHECAL DRUG DELIVERY DEVICES IN ADDITION TO CAUSING DIRECT COMPRESSIVE EFFECTS ON VITAL NEURAL STRUCTURES. THERE HAVE BEEN VERY FEW REPORTED CASES OF CATHETER TIP ASSOCIATED MASSES WITH SOLE BACLOFEN USE. THIS CASE ILLUSTRATES THE CONTINUED NEED FOR VIGILANCE WHEN USING INTRATHECAL BACLOFEN FOR AN INTRATHECAL CATHETER TIP MASS. THE CATHETER TIP MASS IN OUR PATIENT IS NOT CONTRAST ENHANCING WITH T1 WEIGHTED IMAGING. THIS CHARACTERISTIC IS NOT TYPICAL AS MOST CLASSICALLY DESCRIBED INFLAMMATORY MASSES ASSOCIATED WITH INTRATHECAL MORPHINE HAVE AN ENHANCED PERIPHERAL RING LIKE PATTERN ON T1-WEIGHTED IMAGES. EVENT: THE AUTHORS PRESENT A (B)(6) MAN WITH ANOXIC BRAIN INJURY IN 1997 WITH RESULTANT RIGHT SIDED HEMIPARESIS AND SPASTICITY. HE INITIALLY HAD AN ITB PUMP PLACED IN 2000 WITH REPLACEMENT IN 2007. SINCE THEN HE DID HAVE REVISION IN (B)(6) OF 2010 FOR A PROXIMAL KINK WHERE THE PROXIMAL PORTION OF THE CATHETER WAS REPLACED. PRIOR TO THIS, HE HAD REQUIRED ITB DOSE UP TO 1000 MCG/DAY USING A CONCENTRATION OF 2000 MCG/CC OF LIORESAL INTRATHECAL. HE DID WELL UNTIL (B)(6) OF 2010 AT WHICH TIME HE STARTED HAVING INCREASED SPASTICITY ON HIS RIGHT SIDE DESPITE INCREASED DOSES OF ITB AS WELL AS VERY BOTHERSOME RIGHT ARM PAIN. THE PATIENT THEN HAD A CT MYELOGRAM, AFTER ASPIRATION OF CSF, VIA THE SIDE PORT OF THE PUMP SYSTEM SHOWING A PECULIAR CAUDAD FLOW PATTERN. MRI SUBSEQUENTLY SHOWED A CATHETER TIP MASS SEEN BEST ON T2 WEIGHTED IMAGING. THE CATHETER TIP MASS ALSO WAS SEEN LYING BETWEEN THE DORSAL AND VENTRAL ROOTS OF THE C5 SPINAL NERVE. THE CATHETER TIP WAS WITHDRAWN PROXIMALLY ABOUT 2 CM WITH RESOLUTION OF MANY OF THE PATIENT'S ARM SYMPTOMS. UNFORTUNATELY HE CONTINUES TO HAVE INCREASED SPASTICITY. THIS HAS BEEN MANAGED BY DECREASING HIS ITB CONCENTRATION TO 500 MCG/CC AND DECREASING HIS DOSE TO 575 MCG/DAY WITH SUPPLEMENTAL ORAL BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention PROGRAMMER: MODEL PROGRAMMER, LOT# UNKNOWN| EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| IMPLANTED: