BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9078419 · Received September 17, 2019

    Report

    Report Number
    3008766073-2019-00454
    Event Type
    Injury
    Date Received
    September 17, 2019
    Report Date
    August 23, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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: MAGNETIC SPHINCTER AUGMENTATION IS SAFE AND EFFECTIVE FOR THE LONG-TERM TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD). AUTHOR/S: GANZ R.A., BONAVINA L., DEMEESTER T.R., DUNN D.H., LIPHAM J.C., SAINO G., BONA D., FOCKENS P., BEMELMAN W. CITATION: GASTROENTEROLOGY (2009); 136 (5 SUPPL. 1) :A739. DOI: HTTP://DX.DOI.ORG/10.1016/S0016-5085%2809%2963410-7. THE AUTHORS PREVIOUSLY DEMONSTRATED THAT THE LAPAROSCOPIC PLACEMENT OF A MAGNETIC BIOPROSTHESIS (LINX REFLUX MANAGEMENT SYSTEM; ETHICON) AT THE GASTROESOPHAGEAL JUNCTION (GEJ), PROVIDES SAFE AND EFFECTIVE GERD THERAPY ON A SHORT-TERM BASIS. THE AUTHORS NOW EXTEND THOSE OBSERVATIONS TO 12 MONTH FOLLOW-UP. TO DATE 44 PATIENTS (MEAN AGE 42.8) HAVE BEEN IMPLANTED WITH A MEDIAN FOLLOW-UP OF 380 DAYS (RANGE 40-629 DAYS). THE LINX DEVICE (ETHICON) IS A BRACELET OF TITANIUM BEADS, WITH MAGNETIC CORES, LAPAROSCOPICALLY PLACED AROUND THE GASTRO-ESOPHAGEAL JUNCTION (GEJ) IN THE REGION OF THE Z-LINE. REPORTED COMPLICATIONS INCLUDED PERSISTENT DYSPHAGIA (N-1) IN WHICH THE DEVICE WAS REMOVED, AND CHEST DISCOMFORT (N-1) WHICH RESOLVED COMPLETELY AT 55 DAYS. IN CONCLUSION, SPHINCTER AUGMENTATION USING THE LINX DEVICE (ETHICON) APPEARS TO BE A SAFE, AND EFFECTIVE, MINIMALLY-INVASIVE, LONG-TERM GERD THERAPY, BASED ON A SMALL COHORT. THE TREATMENT DOES NOT APPEAR TO PRODUCE LONG-TERM SIDE EFFECTS TYPICAL OF NISSEN FUNDOPLICATION. THE PROCEDURE IS ALSO REVERSIBLE AND PRESERVES NORMAL PHYSIOLOGIC FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873797 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1