BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201194 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02177
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    August 6, 2012
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL: UNK, SERIAL/LOT: UNK. THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THIS EVENT TO A PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    BAHL, A., TRIPATHI, C., MCMULLAN, J., GODDARD, J. NOVEL USE OF INTRATHECAL BACLOFEN DRUG DELIVERY SYSTEM FOR PERIODIC FOCAL DYSTONIA IN A TEENAGER. NEUROMODULATION. 2013;16(3):273-275. DOI: 10.1111/J.1525-1403.2012.00510.X. SUMMARY: FOCAL DYSTONIA, OFTEN AFFECTING PART OF A LIMB, IS A MANIFESTATION OF COMPLEX REGIONAL PAIN SYNDROME (CRPS). THIS CAN BE DIFFICULT TO DIAGNOSE AND TREAT. FURTHERMORE, THERE MAY BE SIGNIFICANT LATENCY BETWEEN THE ONSET OF DYSTONIA AFTER THE DIAGNOSIS OF CRPS. WE PRESENT THE CASE OF A (B)(6) GIRL WITH PERIODIC FOCAL DYSTONIA WHO HAS BEEN SUCCESSFULLY TREATED WITH AN INTRATHECAL BACLOFEN PUMP. THE PATIENT HAD SUSTAINED A MINOR ANKLE FRACTURE FOUR YEARS PRIOR TO PRESENTATION. DESPITE RADIOLOGIC EVIDENCE OF ADEQUATE BONY UNION, THE PATIENT CONTINUED TO COMPLAIN OF SPASMS AND PAIN IN HER LEFT FOOT LEADING TO DYSTONIC POSTURING OF THE FOOT. MULTIPLE THERAPIES INCLUDING SUBCUTANEOUS MORPHINE INFUSION, ANKLE SPLINTING, PHYSIOTHERAPY, AND LOCAL BOTULINUM INJECTIONS HAD NOT PROVIDED ADEQUATE RELIEF. INTRATHECAL BACLOFEN ON THREE SEPARATE OCCASIONS RESULTED IN SUCCESSFUL TEMPORARY RESOLUTION OF THE DYSTONIA. A PLACEBO DOUBLE-BLINDED INJECTION OF INTRATHECAL SALINE AT A SEPARATE SETTING HOWEVER DID NOT RESOLVE THE DYSTONIA. WE THEN PROCEEDED WITH PERMANENT DELIVERY OF BACLOFEN BY IMPLANTATION OF AN INTRATHECAL DRUG DELIVERY PUMP, WHICH RESULTED IN RESOLUTION OF THE DYSTONIA. THE PATIENT ALSO WAS ABLE TO RECEIVE BOLUS DOSES OF INTRATHECAL BACLOFEN. THE PATIENT IS NOW ABLE TO PARTAKE IN SPORTING AND DANCING ACTIVITIES. A DETAILED HISTORY OF THE PATIENT, ALONG WITH THE DIFFICULTIES IN DIAGNOSIS AND MANAGEMENT, IS PRESENTED. INTRATHECAL BACLOFEN THERAPY CAN BE EFFECTIVE IN THE MANAGEMENT OF FOCAL DYSTONIA AFTER RIGOROUS PREOPERATIVE TESTING AND COUNSELING OF ADO LESCENTS WITH CRPS. REPORTED EVENT: THREE MONTHS AFTER INITIAL INSERTION, THE PATIENT UNDERWENT AN ELECTIVE RE-ADMISSION FOR REPOSITIONING OF THE PUMP AS IT WAS IMPINGING ON HER ILIAC CREST DURING ACTIVE EXERCISE. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME;A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301802 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Hospitalization| R