BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 17277203 · Received July 7, 2023

    Report

    Report Number
    3008766073-2023-00137
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    October 27, 2022
    Report Date
    July 7, 2023
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/7/2023. 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/BATCH 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    TITLE: COMPARATIVE OUTCOMES OF ANTI-REFLUX SURGERY IN OBESE PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE. AUTHOR(S): JACQUES A. GREENBERG, FEDERICO PALACARDO, RODRIGO C. L. EDELMUTH, CAITLIN E. EGAN, YEON JOO LEE, FELICE H. SCHNOLL-SUSSMAN, PHILIP O. KATZ, BRENDAN M. FINNERTY, THOMAS J. FAHEY III, RASA ZARNEGAR. CITATION: JOURNAL OF GASTROINTESTINAL SURGERY; HTTPS://DOI.ORG/10.1007/S11605-022-05455-1. THIS STUDY AIMED TO DETERMINE WHETHER PATIENT SATISFACTION AND GASTROESOPHAGEAL REFLUX DISEASE RECURRENCE DIFFERED BETWEEN OBESE AND NON-OBESE PATIENTS WHO UNDERWENT ANTI-REFLUX SURGERY. BETWEEN JANUARY 2012 AND JUNE 2021, 413 PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE WHO UNDERWENT ANTI-REFLUX SURGERY WERE INCLUDED IN THE STUDY. PATIENTS WERE DIVIDED INTO 3 GROUPS ACCORDING BODY MASS INDEX. THERE WERE 294 WITH BMI < 30 KG/M2, 87 WERE 30 KG/M2 = BMI < 35 KG/M2, AND 32 HAD A BMI = 35 KG/M2. PATIENT AGE WAS SIMILAR ACROSS GROUPS (52.6 STD [17.7] VS. 54.2 STD [13.4] VS. 55.2 STD [14.1] YEARS ALTHOUGH THE PROPORTION OF FEMALE SEX WAS HIGHEST IN THE BMI = 35 KG/M2 CATEGORY (57.8% VS. 65.5% VS.84.4%). A TOTAL OF 19 PATIENTS UNDERWENT MAGNETIC SPHINCTER AUGMENTATION USING LINX (ETHICON ENDO-SURGERY) WHILE THE REST OF THE PATIENTS UNDERWENT ROBOTIC ANTI-REFLUX SURGICAL PROCEDURES SUCH AS NISSEN, TOUPET, OR HILL LES AUGMENTATION USING UNSPECIFIED DEVICES (MANUFACTURERS: UNKNOWN). A COMPETITOR PHASIX ST ® MESH (MANUFACTURER: BARD) WAS UTILIZED AT THE SURGEON¿S DISCRETION FOR REINFORCEMENT WHEN THE DIAPHRAGM APPEARED WEAK AFTER REAPPROXIMATION. THE REPORTED COMPLICATIONS INCLUDED RADIOGRAPHIC EVIDENCE OF POSTOPERATIVE REFLUX (N=?), RECURRENT HIATAL HERNIAS ON BARIUM SWALLOW (N=?), UNSPECIFIED EVENTS REQUIRING ESOPHAGEAL DILATION (N=1), AND UNSPECIFIED EVENTS REQUIRING REOPERATION (N=?). IN CONCLUSION, ANTI-REFLUX SURGERY WITH HIATAL HERNIA REPAIR AND LOWER ESOPHAGEAL SPHINCTER AUGMENTATION MAY BE APPROPRIATE FOR SELECT PATIENTS ACROSS A RANGE OF BMIS, INCLUDING THOSE WITH A BMI = 35 KG/M2 WHO ARE HESITANT TO UNDERGO ROUX-EN-Y GASTRIC BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057099 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention