BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5660995 · Received May 17, 2016

    Report

    Report Number
    3007566237-2016-02016
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    August 1, 2015
    Report Date
    September 20, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637, PRODUCT TYPE: PUMP. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KISHIMA, H. [INTRATHECAL BACLOFEN THERAPY FOR CEREBRAL PALSY]. NO SHINKEI GEKA. NEUROLOGICAL SURGERY. 2015;43(8):681-690. DOI: 10.11 477/MF.1436203102. SUMMARY: IN THIS PAPER, I WILL DISCUSS IN DETAIL THE SUMMARY, SURGERIES, EFFECTS, COMPLICATIONS, AND MAINTENANCE METHODS, ETC. IN ITB THERAPY FOR CEREBRAL PALSY, ALONG WITH SOME RECENT FINDINGS. REPORTED EVENTS: IN OUR SERIES OF 40 CASES, INTRATHECAL CATHETER DEPARTURE AND ABERRATION HAVE BEEN OBSERVED IN MULTIPLE CASES. IN PARTICULAR, IN ONE CASE OF HEREDITARY SPASTIC PARAPLEGIA, MULTIPLE INSTANCES OF DEPARTURE AND ABERRATION HAVE BEEN OBSERVED. WE PERFORMED RE-SURGERY ON ALL CASES WITH COMPLICATIONS DUE TO THE CATHETER, AND CONTINUED ITB THERAPY ON THEM. WE HAVE OBSERVED A SUICIDE ATTEMPT CASE WHOSE CAUSAL RELATIONSHIP WITH THIS TREATMENT IS NOT CLEAR. ONE CASE WAS DISCONTINUED ; THE PATIENT WAS DIAGNOSED WITH ADRENOLEUKODYSTROPHY AND SHOWED RAPID DECREASE IN ADL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) INDICATED THE CASES OF CATHETER DEPARTURE AND ABERRATION WERE ALREADY REPORTED IN THE FOLLOWING MANUFACTURER REPORTS: #6000030-2007-025, #2182207-2007-02930, #3004209178-2010-10214, #3004209178-2011-00847, #6000030-2011-05117, #3004209178-2011-06725, #3004209178-2011-07079, #3004209178-2011-06399, #3004209178-2011-06400, #6000030-2011-08785, #3007566237-2012-00435, AND #3004209178-2014-05822.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316405 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R