BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3474467 · Received November 18, 2013

    Report

    Report Number
    3007566237-2013-03736
    Event Type
    Injury
    Date Received
    November 18, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE WAS NOT PROVIDED; THIS DATE WAS BASED ON THE DATE THE ARTICLE WAS PUBLISHED. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4) .

    Description of Event or Problem · 1

    POSTERARO, F., CALANDRIELLO, B., GALLI, R., LOGI, F., LARDELLA, L., BORDI, L. TIMING OF INTRATHECAL BACLOFEN THERAPY IN PERSONS WITH ACQUIRED BRAIN INJURY: INFLUENCE ON OUTCOME. BRAIN INJURY. 2013. SUMMARY: THIS INVESTIGATION WAS A (B)(6) STUDY, INCLUDING A SERIES OF 13 ABI IMPLANTED WITHIN 6 MONTHS OF THE ACUTE EVENTS. THE MODIFIED ASHWORTH SCALE (MAS) AND SPASMS FREQUENCY SCORE (SFS)HAVE BEEN USED AS A PRIMARY OUTCOME MEASURE. THE DISABILITY RATING SCALE (DRS) AND LEVEL OF COGNITIVE FUNCTIONING (LCF) SCORES HAVE BEEN COMPUTED IN ORDER TO VERIFY POSSIBLE INTERFERENCES OF BACLOFEN THERAPY AT AN EARLY STAGE ON A GLOBAL OUTCOME. AN INTRATHECAL BOLUS TEST WAS NOT PERFORMED. DRUG TOLERABILITY WAS TESTED BY ORAL ADMINISTRATION OF BACLOFEN 100 MG. REDUCTION OF SPASTICITY AND SPASMS FREQUENCY WERE MEASURED 3 MONTHS AFTER PATIENTS RECEIVED THE IMPLANT AND AT THE 1-YEAR FOLLOW-UP. THERE WAS NO DIFFERENCE FOUND FOR GLOBAL OUTCOME MEASURE BETWEEN THE GROUP OF PATIENTS WHO RECEIVED THE IMPLANT EARLIER (WITHIN 3 MONTHS) COMPARED TO THE GROUP WHO RECEIVED IT LATER (BETWEEN 3¿6 MONTHS). ITB THERAPY IN ABI SHOULD BE CONSIDERED AS EARLY AS POSSIBLE. THE IMPLANTS ARE SAFE AND EFFECTIVE IN REDUCING SPASTICITY. AN INTRATHECAL BOLUS TEST WAS NOT COMPULSORY IN ABI. REPORTED EVENT: THREE PATIENTS EXPERIENCED SURGICAL POCKET SEROMAS WHICH WERE TREATED SUCCESSFULLY WITH ANTIBIOTICS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR INDICATED THAT, IN THE STUDY, 2MG/ML LIORESAL WAS USED TO FILL THE PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596424 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention