BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 11574101 · Received March 26, 2021

    Report

    Report Number
    3008766073-2021-00053
    Event Type
    Injury
    Date Received
    March 26, 2021
    Date of Event
    October 17, 2020
    Report Date
    March 9, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE CONFIRM IF THE MSA MENTIONED IN THE JOURNAL ARTICLE IS CONSIDERED AN ETHICON PRODUCT. IS IT THE TORAX LINX DEVICE FROM ETHICON? YES, IT WAS A TORAX LINX DEVICE FROM ETHICON.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: MAGNETIC SPHINCTER AUGMENTATION AT THE TIME OF BARIATRIC SURGERY: AN ANALYSIS OF THE MBSAQIP AUTHORS: BENJAMIN CLAPP, M.D., F.A.S.M.B.S., CHRISTOPHER DODOO, M.S., BRITTANY HARPER, M.D., JISOO KIM, M.D. CHRISTIAN CASTRO, B.S., MARAH HAMDAN, B.S., SAMUEL GRASSO, D.O., AND BRIAN DAVIS, M.D CITATION: SURGERY FOR OBESITY AND RELATED DISEASES 17 (2021) 555¿561/ DOI.ORG/10.1016/J.SOARD.2020.10.024. THE AIM OF THIS STUDY IS TO DETERMINE THE SHORT-TERM OUTCOMES OF MAGNETIC SPHINCTER AUGMENTATION (MSA) PLACED AT THE TIME OF METABOLIC AND BARIATRIC SURGERY (MBS). BETWEEN 2017 AND 2018, THE AUTHORS QUERIED THE METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM (MBSAQIP) DATABASE FOR MSA PERFORMED AT TIME OF THE SLEEVE GASTRECTOMY (SG) AND ROUXEN-Y GASTRIC BYPASS (RYGB). AMONG THE 319,580 PATIENTS WHO UNDERWENT MBS IN THE STUDY PERIOD, 24 PATIENTS HAD MSA AT TIME OF SURGERY. SIX PATIENTS WITH MSA HAD A RYGB AND THE OTHER 18 PATIENTS HAD SG. ONE PATIENT WAS READMITTED DUE TO NAUSEA. MSA IS BEING PLACED PROPHYLACTICALLY IN WHICH THE AUTHORS THINK IS AN OFF-LABEL USE AND IT IS UNKNOWN AT THIS TIME IF PROPHYLACTIC PLACEMENT IS JUSTIFIED. MSA AT THE TIME OF MBS DOES NOT INCREASE COMPLICATIONS IN THE SHORT-TERM. THERE IS NO DIFFERENCE IN MORBIDITY OR MORTALITY. OPERATIVE TIMES ARE SIMILAR IN MSA PATIENTS. ONLY CLOSE LONG-TERM FOLLOW-UP WILL DETERMINE IF MSA PERFORMED AT THE TIME OF PRIMARY MBS IS EFFECTIVE AND SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470324 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R