BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9153051 · Received October 3, 2019

    Report

    Report Number
    3008766073-2019-00512
    Event Type
    Injury
    Date Received
    October 3, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 10/03/2019. 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: MAGNETIC SPHINCTER AUGMENTATION WITH THE LINX DEVICE FOR GASTROESOPHAGEAL REFLUX DISEASE AFTER U.S. FOOD AND DRUG ADMINISTRATION APPROVAL. AUTHOR/S: REYNOLDS J.L., ZEHETNER J., BILDZUKEWICZ N., KATKHOUDA N., DANDEKAR G., LIPHAM J.C. CITATION: AMERICAN SURGEON. 2014 OCT 01; 80 (10) :1034-1038. THIS IS A PROSPECTIVE OBSERVATIONAL STUDY OF ALL PATIENTS WHO UNDERWENT PLACEMENT OF THE LINX (ETHICON) AT TWO INSTITUTIONS FROM APRIL 2012 TO DECEMBER 2013 TO EVALUATE A CLINICAL EXPERIENCE WITH THE LINX DEVICE AFTER FDA APPROVAL. REPORTED COMPLICATION INCLUDED DYSPHAGIA (N-?) WHICH RESOLVED IN 79.1% OF PATIENTS WITH A MEDIAN TIME TO RESOLUTION OF EIGHT WEEKS. 8 PATIENTS REQUIRED BALLOON DILATION WITH IMPROVEMENT IN SYMPTOMS. IN CONCLUSION, MSA WITH LINX IS A SAFE AND EFFECTIVE ALTERNATIVE TO FUNDOPLICATION FOR TREATMENT OF GERD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947976 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1