BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9139308 · Received October 1, 2019

    Report

    Report Number
    3008766073-2019-00486
    Event Type
    Injury
    Date Received
    October 1, 2019
    Report Date
    September 17, 2019
    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). 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: POST-OPERATIVE DYSPHAGIA FOLLOWING MAGNETIC SPHINCTER AUGMENTATION FOR GASTROESOPHAGEAL REFLUX DISEASE. AUTHOR/S: TSAI C., KESSLER U., STEFFEN R., ZEHETNER J. CITATION: SURGICAL ENDOSCOPY. 2019 APR; CONFERENCE: 2019 SCIENTIFIC SESSION OF THE SOCIETY OF AMERICAN GASTROINTESTINALAND ENDOSCOPIC SURGEONS, SAGES. UNITED STATES. 33 (SUPPLEMENT 1) :S336; HTTP://DX.DOI.ORG/10.1007/S00464. THE AIM OF THIS STUDY WAS TO EVALUATE PREDICTORS OF PERSISTENT POST-OPERATIVE DYSPHAGIA LEADING TO INTERVENTION, AS WELL AS ITS IMPACT ON QUALITY OF LIFE. FROM AUGUST 2015 TO SEPTEMBER 2018, 118 PATIENTS (M = 59, F = 59) WITH MEAN AGE WAS 50 YEARS (R18-80) WERE INCLUDED IN THE STUDY. THE AUTHORS REVIEWED THE ELECTRONIC MEDICAL RECORDS OF ALL PATIENTS WITH GERD RECEIVING A LAPAROSCOPIC MSA (LINX REFLUX MANAGEMENT SYSTEM, TORAX MEDICAL) WITH POSTERIOR CRUROPLASTY (PC). POST-OPERATIVE DYSPHAGIA WAS PRESENT IN 80 PATIENTS. OF THEM, 20 REQUIRED BALLOON DILATION FOR PERSISTENT DYSPHAGIA. PATIENTS RECEIVED A MEDIAN OF 1 DILATION AT A MEAN OF 5.6 MONTHS (R1-13) AFTER MSA-PC. THE MSA DEVICE WAS EXPLANTED IN TWO PATIENTS, WHILE DYSPHAGIA RESOLVED IN 15 PATIENTS. TWO PATIENTS HAVE PERSISTENT SYMPTOMS AND THE REMAINING PATIENT HAS INSUFFICIENT FOLLOW-UP. COMPARED TO PATIENTS WHO DID NOT REQUIRE DILATION, DILATED PATIENTS WERE MORE LIKELY TO HAVE ATYPICAL GERD SYMPTOMS PRE-OPERATIVELY. HOWEVER, 92.3% OF NON-EXPLANTED PATIENTS REQUIRING DILATION REPORTED AN IMPROVED QUALITY OF LIFE. IN CONCLUSION, ALTHOUGH POSTOPERATIVE DYSPHAGIA IS A COMMON TEMPORARY SIDE EFFECT AFTER MSA-PC, AND THIS IS MOST COMMONLY SEEN IN PATIENTS WITH ATYPICAL GERD SYMPTOMS PRE-OPERATIVELY. MOST CASES OF PERSISTENT DYSPHAGIA CAN BE TREATED WITH A SINGLE BALLOON DILATION. DESPITE REQUIRING A DILATION, THE MAJORITY OF PATIENTS STILL REPORT AN IMPROVED QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934466 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1