BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9040560 · Received September 13, 2019

    Report

    Report Number
    3008766073-2019-00451
    Event Type
    Injury
    Date Received
    September 13, 2019
    Report Date
    August 15, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? RESPONSE: THE ANSWERS TO BOTH QUESTIONS IS NO. 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. PER THE ARTICLE ONE PATIENT HAD SEVERE DYSPHAGIA AND DEMANDED THE REMOVAL OF THE LINX SYSTEM AFTER 18 DAYS OF ITS PLACEMENT AND WAS REMOVED FROM THE FOLLOW-UP. HOW SEVERE WAS THE DYSPHAGIA PRIOR TO IMPLANT? POST IMPLANT WAS THERE ANY IMPROVEMENT WITH THE DYSPHAGIA? HAVE THE SYMPTOMS RESOLVED SINCE THE DEVICE WAS EXPLANTED?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LAPAROSCOPIC PLACEMENT OF THE LINX SYSTEM IN MANAGEMENT OF SEVERE REFLUX AFTER SLEEVE GASTRECTOMY. AUTHORS: ABDELKADER HAWASLI; MOUTAMN SADOUN; AHMED MEGUID; MOSAB DEAN; MOHAMAD SAHLY; BIANCA HAWASLI. CITATION: THE AMERICAN JOURNAL OF SURGERY 217 (2019) 496-499; HTTPS://DOI.ORG/10.1016/J.AMJSURG.2018.10.040. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TREATING SEVERE REFRACTORY REFLUX, AFTER SLEEVE GASTRECTOMY (SG), USING THE LINX SYSTEM IN PATIENTS WHO REFUSED THE ROUX-EN-Y GASTRIC BYPASS (RYGB ) OPTION. BETWEEN JANUARY 2015 AND DECEMBER 2017, 13 PATIENTS (FEMALES=10, MALE=3; MEAN AGE=49 ± 13 YEARS; MEAN BMI=46 ± 8 KG/M^2) HAD PLACEMENT OF THE LINX (ETHICON) SYSTEM TO MANAGE THEIR SEVERE ACID REFLUX AFTER SG AFTER FAILED MEDICAL MANAGEMENT. REPORTED COMPLICATIONS INCLUDED SEVERE DYSPHAGIA (N=1) THAT DEMANDED REMOVAL OF THE LINX SYSTEM AFTER 18 DAYS OF PLACEMENT; MILD AND OCCASIONAL RECURRENT REFLUX DEPENDING ON WHAT THE PATIENTS¿ ATE (N=3) WHICH THEY TOOK OCCASIONAL PROTON PUMP INHIBITOR (PPI); RECURRENT REFLUX (N=3) WHICH REQUIRED DAILY INTAKE OF PPI BUT TO LESSER DEGREE THAN THEIR ORIGINAL PPI INTAKE BEFORE THE PLACEMENT OF THE LINX. IN CONCLUSION, THE LAPAROSCOPIC PLACEMENT OF THE LINX SYSTEM FOR MANAGEMENT OF SEVERE REFRACTORY REFLUX AFTER SG IS SAFE AND MAY BE OFFERED AS AN ALTERNATIVE TO THE CONVERSION TO RYGB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823329 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1