BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9007568 · Received September 12, 2019

    Report

    Report Number
    3008766073-2019-00443
    Event Type
    Injury
    Date Received
    September 12, 2019
    Report Date
    August 15, 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: LINX DEVICE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY: A CAUTIONARY TALE. AUTHOR/S: HAWKINS R.B., DESSAIGNE C.G., AYZENGART A.L. CITATION: SURG ENDOSC (2018); 32:S130¿S359. DOI: HTTP://DX.DOI.ORG/10.1007/S00464-018-6121-4 . THE AUTHORS PRESENTED A CASE OF A PATIENT WITH PRIOR SLEEVE GASTRECTOMY WHO RECEIVED A LINX DEVICE (ETHICON) ONE YEAR AFTER HER BARIATRIC OPERATION DUE TO SEVERE GASTROE-SOPHAGEAL REFLUX DISEASE (GERD) REFRACTORY TO MEDICAL MANAGEMENT. SOON AFTER LINX (ETHICON) IMPLANTATION, THE FEMALE PATIENT DEVELOPED PROGRESSIVE DYSPHAGIA AND WORSENED REFLUX. REPEAT EVALUATION SHOWED ESOPHAGITIS, A MODERATE STRICTURE WITH ANGULATION AT THE INCISURA, AND A LARGE AMOUNT OF RETAINED FOOD. THE PATIENT UNDERWENT LAPAROSCOPIC REMOVAL OF THE LINX DEVICE (ETHICON) WITH HIATAL HERNIA REPAIR AND GASTRIC STRICTUROPLASTY. POST-OPERATIVE FLUORO-SCOPIC EVALUATION REVEALED IMPROVEMENT IN THE STRICTURE, BUT PERSISTENT GASTROESOPHAGEAL REFLUX. THE PATIENT EXPERIENCED A SIGNIFICANT IMPROVEMENT IN HER SYMPTOMS OF DYSPHAGIA, NAUSEA, AND VOMITING. IN CONCLUSION, CONVERSION TO ROUX-EN-Y GASTRIC BYPASS REMAINS THE STANDARD APPROACH TO TREATMENT OF GERD POST SLEEVE GASTRECTOMY. CAREFUL DIAGNOSTIC EVALUATION PRIOR TO PLACEMENT OF MAGNETIC SPHINCTER AUGMENTATION DEVICE SHOULD BE ROUTINELY UNDERTAKEN. POSTOPERATIVELY, CLOSE LONG-TERM FOLLOW UP IS IMPERATIVE, PARTICULARLY IN PATIENTS WITH PRIOR SLEEVE GASTRECTOMY. PRESENCE OF LINX IN A PATIENT WITH PRIOR BARIATRIC SURGERY MAY LEAD TO WORSENING SYMPTOMS IF COMPLICATIONS OF INITIAL OPERATION ARE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811290 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1