BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 11569484 · Received March 25, 2021

    Report

    Report Number
    3008766073-2021-00051
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    September 28, 2020
    Report Date
    March 9, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2020 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: IN THIS JOURNAL ARTICLE, PLEASE CONFIRM IF LINX (ETHICON) (AS MENTIONED IN THE KEYWORDS) CAN BE PRESUMED AS THE DEVICE USED IN THE MSA? FOR THE PATIENTS THAT WERE PUT ON PPI¿S, WERE THE PPI¿S OVER THE COUNTER? WERE THE PPI¿S DOCTOR PRESCRIBED? ANSWER = MSA DOES MEAN LINX. FOR THE PPIS, THE DATA WAS NOT COLLECTED WHETHER THE PPI WAS DOCTOR PRESCRIBED OR OTC.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: SAFETY OF MAGNETIC SPHINCTER AUGMENTATION IN PATIENTS WITH PRIOR BARIATRIC AND ANTI-REFLUX SURGERY. AUTHOR: STEVEN G. LEEDS, ANDREW NGOV, GERALD O. OGOLA AND MARC A. WARD CITATION: NOT REPORTED. DOI: HTTPS://DOI.ORG/10.1007/S00464-020-08025-1. THIS STUDY AIMS TO EVALUATE THE SAFETY AND EFFICACY OF MSA IN PATIENTS WITH PRIOR GASTRIC SURGERY INCLUDING BARIATRIC AND OTHER ANTI-REFLUX OPERATIONS. A TOTAL OF 103 PATIENTS UNDERWENT MAGNETIC SPHINCTER AUGMENTATION (MSA) (PRESUMED LINX) (ETHICON) WHERE 82 PATIENTS HAD NO PRIOR GASTRIC SURGERY (NGS) (AGE MEAN 50.6 ± 16.2, MALE N=41, FEMALE N=41 AND BMI 28.3 ± 4.9) AND 21 PATIENTS HAD PRIOR GASTRIC SURGERY (PGS) (AGE MEAN 58.2 ± 9.3, MALE N=1, FEMALE N=20 AND BMI OF 29.1 ± 4.8). POSTOPERATIVELY, PATIENTS REPORTED BEING DISSATISFIED (NGS N=7 AND PGS N=2), ON PPI (NGS N=5 AND PGS N=3) AND THEIR DEVICE WAS REMOVED (NGS N=7 AND PGS N=2). THIS STUDY DEMONSTRATES EQUIVALENT OUTCOMES WITH INTEGRATION OF MSA IN PATIENTS WITH PRIOR GASTRIC SURGERY IN COMPARISON TO PATIENTS WITHOUT PRIOR GASTRIC SURGERY. HOWEVER, THESE SURGERIES ARE LONGER, REQUIRE LARGER DEVICES, AND PATIENTS ARE MORE LIKELY TO STAY OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469118 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention