BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 7999709 · Received October 24, 2018

    Report

    Report Number
    2210968-2018-76727
    Event Type
    Injury
    Date Received
    October 24, 2018
    Report Date
    October 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: STEREOTACT FUNCT NEUROSURG. 2016; 94: 18¿23. DOI: 10.1159/000442893. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "NOVEL APPROACH TO SECURING DEEP BRAIN STIMULATION LEADS: TECHNIQUE AND ANALYSIS OF LEAD MIGRATION, BREAKAGE, AND SURGICAL INFECTION." AUTHORS: GABRIELLE A. WHITE-DZURO A WENDELL LAKE B ILYAS M. ELI C JOSEPH S. NEIMAT, . CITATION: STEREOTACT FUNCT NEUROSURG. 2016; 94: 18¿23. DOI: 10.1159/000442893. DEEP BRAIN STIMULATION (BDS) IS A BENEFICIAL THERAPY FOR PARKINSON¿S DISEASE, ESSENTIAL TREMOR, AND SEVERAL OTHER DISORDERS. FIXATION OF THE ELECTRODE DURING DBS SURGERY IS AN IMPORTANT ASPECT OF THE PROCEDURE. THE AUTHORS HAVE DEVELOPED AN ALTERNATIVE METHOD FOR SECURING LEADS THAT UTILIZES A TITANIUM HEMOCLIP AND CEMENT. THIS TECHNIQUE IS DESCRIBED, AND THE RATES OF COMPLICATIONS ARE COMPARED TO CONVENTIONAL METHODS OF SECURING LEADS. A TOTAL OF 291 DBS OPERATIONS PERFORMED BY A SINGLE SURGEON WERE RETROSPECTIVELY ANALYZED. DURING THE SURGICAL PROCEDURE, USING NEUROLON 4-0 SUTURE (ETHICON), THE LEAD IS TIED TO THE PERICRANIUM IN TWO SEPARATE PLACES AS IT IS COILED AROUND THE BUR HOLE. THE BOOT AND LEAD COVER ARE PLACED ON THE LEADS, AND THE DEVICES ARE TUNNELED TO A SUBGALEAL POCKET. THE WOUND IS THEN CLOSED IN LAYERS. REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION (N-9), LEAD FRACTURES (N-4), AND LEAD MIGRATION (N-8) WHICH REQUIRED SURGICAL READJUSTMENT OF THE POSITION OF DBS LEADS. THE AUTHORS DESCRIBED A METHOD FOR SECURING DBS LEADS AND SHOWED AN ACCEPTABLE INCIDENCE OF HARDWARE COMPLICATIONS WHEN COMPARED TO THE CONVENTIONAL METHOD. THE AUTHORS FEEL THIS TECHNIQUE HAS IMPROVED COSMETIC RESULTS AND SHOULD BE CONSIDERED AS A METHOD FOR SECURING DBS LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842567 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DBS ELECTRODE LEAD