BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2460647 · Received February 17, 2012

    Report

    Report Number
    3007566237-2012-00348
    Event Type
    Injury
    Date Received
    February 17, 2012
    Date of Event
    March 1, 2008
    Report Date
    February 24, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONTINUED CONCOMITANT MEDICAL PRODUCTS. (B)(6) 2008 EXPLANTED: (B)(6) 2008.

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATE WAS NOT PROVIDED. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    DEON, L. L., KALICHMAN, M. A., BOOTH, C. L., SLAVIN, K. V., GAEBLER-SPIRA, D. J. PALLIDAL DEEP-BRAIN STIMULATION ASSOCIATED WITH COMPLETE REMISSION OF SELF-INJURIOUS BEHAVIORS IN A PATIENT WITH LESCH-NYHAN SYNDROME: A CASE REPORT. J CHILD NEUROL 2012; 27: 117. PUBLISHED ONLINE (B)(4), 2011. DOI: 10.1177/0883073811415853. SUMMARY: THE PURPOSE OF THIS CASE REPORT IS TO REVIEW THE MANAGEMENT OF A BOY WITH LESCH-NYHAN SYNDROME WITH DEEP-BRAIN STIMULATION WHO HAD REMISSION OF SELF-INJURIOUS BEHAVIORS AS A RESULT. THIS PATIENT WAS TREATED WITH INTRATHECAL BACLOFEN AND, LATER, WITH DEEP-BRAIN STIMULATION TO REDUCE HYPERTONIA. GOALS WERE TO IMPROVE WHEELCHAIR POSITIONING FOR SCHOOL ATTENDANCE AND TO REDUCE THE USE OF RESTRAINTS FOR COMFORT. INTRATHECAL BACLOFEN WAS IMPLANTED TWICE AND DECREASED THE HYPERTONIA, BUT BOTH WERE EXPLANTED BECAUSE OF INFECTION. DEEP-BRAIN STIMULATION WAS INITIATED 2.5 YEARS AGO, AND SINCE THAT TIME, COMFORT AND FUNCTION HAVE IMPROVED AND CAREGIVER BURDEN HAS DECREASED. IMPROVEMENTS IN DYSTONIA WITH DEEP-BRAIN STIMULATION HAVE ALSO OCCURRED, AND SELF-INJURIOUS BEHAVIORS HAVE RESOLVED. ADDITIONAL INFORMATION RECEIVED STATED THE DRUG WAS LIORESAL 500MCG/ML DELIVERED AT 50MCG/DAY. A CULTURE WAS OBTAINED AND YIELDED (B)(6) AND (B)(6). VANCOMYCIN WAS THE ANTIBIOTIC ADMINISTERED. THE WOUND HAD TO BE RE-CLOSED A FEW WEEKS AFTER EXPLANT OF THE PUMP, BUT THE PATIENT EVENTUALLY HEALED WELL.

    Description of Event or Problem · 1

    DEON, L. L., KALICHMAN, M. A., BOOTH, C. L., SLAVIN, K. V., GAEBLER-SPIRA, D. J. PALLIDAL DEEP-BRAIN STIMULATION ASSOCIATED WITH COMPLETE REMISSION OF SELF-INJURIOUS BEHAVIORS IN A PATIENT WITH LESCH-NYHAN SYNDROME: A CASE REPORT. J CHILD NEUROL 2012; 27: 117. PUBLISHED ONLINE (B)(6) 2011. DOI: 10.1177/0883073811415853. SUMMARY: THE PURPOSE OF THIS CASE REPORT IS TO REVIEW THE MANAGEMENT OF A BOY WITH LESCH-NYHAN SYNDROME WITH DEEP-BRAIN STIMULATION WHO HAD REMISSION OF SELF-INJURIOUS BEHAVIORS AS A RESULT. THIS PATIENT WAS TREATED WITH INTRATHECAL BACLOFEN AND, LATER, WITH DEEP-BRAIN STIMULATION TO REDUCE HYPERTONIA. GOALS WERE TO IMPROVE WHEELCHAIR POSITIONING FOR SCHOOL ATTENDANCE AND TO REDUCE THE USE OF RESTRAINTS FOR COMFORT. INTRATHECAL BACLOFEN WAS IMPLANTED TWICE AND DECREASED THE HYPERTONIA, BUT BOTH WERE EXPLANTED BECAUSE OF INFECTION. DEEP-BRAIN STIMULATION WAS INITIATED 2.5 YEARS AGO, AND SINCE THAT TIME, COMFORT AND FUNCTION HAVE IMPROVED AND CAREGIVER BURDEN HAS DECREASED. IMPROVEMENTS IN DYSTONIA WITH DEEP-BRAIN STIMULATION HAVE ALSO OCCURRED, AND SELF-INJURIOUS BEHAVIORS HAVE RESOLVED. REPORTED EVENT: A SECOND INTRATHECAL BACLOFEN PUMP WAS PLACED 2 MONTHS AFTER FIRST ONE WAS EXPLANTED, BUT IT HAD TO BE REMOVED 4 WEEKS LATER BECAUSE OF INFECTION. BECAUSE BOTH INTRATHECAL BACLOFEN PUMPS WERE REMOVED SHORTLY AFTER PLACEMENT, IT WAS DIFFICULT TO EVALUATE A COMPLETE FUNCTIONAL RESPONSE, ALTHOUGH THE PATIENT DID HAVE IMPROVED UPPER EXTREMITY POSITIONING. SEE MFR REPORT# 3007566237-2012-00347 FOR EVENT RELATED TO PATIENT'S FIRST INTRATHECAL BACLOFEN PUMP. FURTHER INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention CATHETER MODEL UNKNOWN, LOT/SERIAL# UNKNOWN| CATHETER MODEL 8709SC, LOT# N134253001