BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9141929 · Received October 1, 2019

    Report

    Report Number
    3008766073-2019-00499
    Event Type
    Injury
    Date Received
    October 1, 2019
    Report Date
    September 19, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 10/01/2019. DATE OF EVENT: UNKNOWN. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: CRURAL CLOSURE IMPROVES OUTCOMES OF MAGNETIC SPHINCTER AUGMENTATION IN GERD PATIENTS WITH HIATAL HERNIA. AUTHOR: KATRIN SCHWAMEIS, MILENA NIKOLIC, DEIVIS G. MORALES CASTELLANO, ARIANE STEINDL, SARAH MACHECK, M. RIEGLER, IVAN KRISTO , BARBARA ZORNER & SEBASTIAN F. SCHOPPMANN. CITATION: SCIENTIFIC REPORTS (2018) 8:7319; DOI: 10.1038/S41598-018-24322-1. THIS RETROSPECTIVE STUDY AIMED TO ASSESS IF HIATAL REPAIR IN MAGNETIC SPHINCTER-AUGMENTATION (MSA) PATIENTS SIGNIFICANTLY INFLUENCES POSTOPERATIVE OUTCOMES INCLUDING REFLUX CONTROL AND DYSPHAGIA RATE. BETWEEN MARCH 2012 AND MAR 2017, A TOTAL OF 68 PATIENTS (N=46 MALES, N=22 FEMALES; MEDIAN AGE OF 45 YEARS, RANGE OF 38-58) WERE INCLUDED IN THE STUDY. THE PATIENTS WERE CLASSIFIED INTO 3 GROUPS: ¿NO HIATAL HERNIA¿ (NHH) (N=16), ¿HIATAL REPAIR¿ (HR) (N=26) AND ¿NO HIATAL REPAIR¿ (NHR) (N=26) GROUP. THE SURGICAL APPROACH WAS LAPAROSCOPIC IN ALL CASES. AFTER MOBILIZATION OF THE ESOPHAGOGASTRIC JUNCTION, THE ADEQUATE RING SIZE WAS MEASURED WITH THE SIZING TOOL AND THE MAGNETIC DEVICE (LINX REFLUX MANAGEMENT SYSTEM, ETHICON) WAS WRAPPED AROUND THE LOWER END OF THE LOWER ESOPHAGEAL SPHINCTER. COMPLAINT INCLUDED RETROSTERNAL PAIN (N=1 FROM HR GROUP) AND DISCOMFORT (N=1 FROM NHR GROUP). THE DEVICE WAS EXPLANTED IN BOTH PATIENTS DUE TO THE EVENTS. ADDITIONAL COMPLAINT OF RARE DIFFICULTIES SWALLOWING SOLIDS (N = 14) AND OCCASIONAL DIFFICULTIES WITH SWALLOWING SOLIDS (N = 11) WERE REPORTED. MAGNETIC LOWER ESOPHAGEAL SPHINCTER (LES) AUGMENTATION LEADS TO SIGNIFICANT GASTROINTESTINAL SYMPTOM RELIEF, INCREASED GERD-SPECIFIC QUALITY OF LIFE AND GOOD ALIMENTARY SATISFACTION WITH LOW PERIOPERATIVE MORBIDITY RATES. IN PATIENTS WITH HIATAL HERNIA, CRURAL CLOSURE TENDS TO RESULT IN BETTER REFLUX CONTROL AND GERD SYMPTOM RELIEF COMPARED TO EXCLUSIVE MSA WITHOUT INCREASING POSTOPERATIVE DYSPHAGIA RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934456 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1