BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 11008388 · Received December 15, 2020

    Report

    Report Number
    2210968-2020-09914
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    September 28, 2020
    Report Date
    November 25, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (NUROLON SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (PERIOPERATIVE INFECTION, NONOPERATIVE INFECTIONS, LACK OF EFFICACY, DEVICE PAIN/DISCOMFORT, PROGRESSIVE MOTOR WEAKNESS) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (NUROLON SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ABOVE. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: NEUROMODULATION 2020; E-PUB; DOI:10.1111/NER.13295. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: DIRECT PERIPHERAL NERVE STIMULATION FOR THE TREATMENT OF COMPLEX REGIONAL PAIN SYNDROME: A 30-YEAR REVIEW". AUTHORS: MARK A. CHMIELA, MD; MARK HENDRICKSON, MD; JASON HALE, MD; CHEN LIANG, MS; PHILLIP TELEFUS, MD; AFRIN SAGIR, MD; MICHAEL STANTON-HICKS, MD. CITATION: NEUROMODULATION 2020; E-PUB; DOI:10.1111/NER.13295. THE AIM OF THIS RETROSPECTIVE STUDY WERE TO INVESTIGATE PERIPHERAL NERVE STIMULATION (PNS) EFFICACY AS DETERMINED BY VISUAL ANALOG SCALES (VAS) SCORE, ORAL OPIOID CONSUMPTION, FUNCTIONAL OUTCOME, AND TO CATALOG THE PREVALENCE OF VARIOUS COMPLICATIONS OVER AN EXTENDED TIME PERIOD. FROM 1990 TO 2017, A TOTAL OF 240 PATIENTS WERE IDENTIFIED WHO HAD RECEIVED PERIPHERAL NERVE STIMULATORS FOR THE TREATMENT OF NEUROPATHIC PAIN. OF THESE, 165 (FEMALE=86; MEAN AGE AT TIME OF IMPLANT=42 ± 11 YEARS; BMI 29 ± 7) HAD RECEIVED A DIAGNOSIS OF COMPLEX REGIONAL PAIN SYNDROME (CRPS). DURING THE PROCEDURE, EACH ELECTRODE WAS SUTURED TOGETHER ALONG THEIR ADJACENT GORE-TEX EDGES TO FORM A ¿SANDWICH¿ THAT WAS PLACED AROUND THE SCIATIC NERVE TAKING CARE THAT EACH ELECTRODE WAS IN PRECISE CONTACT WITH THE POSTERIOR TIBIAL AND PERONEAL DIVISIONS. THE ELECTRODE NERVE COMPLEX WAS RETAINED WITH PERINEURAL 4-0 NUROLON SUTURE (ETHICON). A SINGLE ON-POINT ELECTRODE WAS ATTACHED TO THE PERINEURIUM USING 4-0 NUROLON SUTURES. THE NERVE AND ELECTRODE GRAFT WERE ATTACHED TO THE PERINEURIUM WITH 4-0 NUROLON SUTURES AND THE COMPLEX RETURNED TO THE NORMAL POSITION OF THE NERVE. REPORTED COMPLICATIONS INCLUDED COVERAGE FAILURE/WORSENING SYMPTOMS (N=22) WITH REVISION; PERIOPERATIVE INFECTIONS (N=3) DEFINED AS INFECTION REQUIRING TREATMENT OR EXPLANTATION WITHIN SIX WEEKS OR SURGICAL IMPLANTATION; NONOPERATIVE INFECTIONS (N=10) DEVELOPED SIX WEEKS OR LATER FOLLOWING IMPLANT OR REVISION; LACK OF EFFICACY (N=16) REQUIRING EXPLANTATION; INFECTION (N=9) REQUIRING EXPLANTATION; DEVICE PAIN/DISCOMFORT (N=2) REQUIRING EXPLANTATION; PROGRESSIVE MOTOR WEAKNESS (N=1) REQUIRING EXPLANTATION; UNKNOWN REASON (N=1) REQUIRING EXPLANTATION. IN CONCLUSION, PNS IS A USEFUL MODALITY TO IMPROVE FUNCTION AND REDUCE LONG-TERM PAIN IN SELECTED PATIENTS SUFFERING FROM CRPS TYPE I AND TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475819 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention