BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9141586 · Received October 1, 2019

    Report

    Report Number
    3008766073-2019-00498
    Event Type
    Injury
    Date Received
    October 1, 2019
    Report Date
    September 18, 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: 10/01/2019. 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: HIATAL HERNIA RECURRENCE FOLLOWING MAGNETIC SPHINCTER AUGMENTATION AND POSTERIOR CRUROPLASTY: INTERMEDIATE-TERM OUTCOMES. AUTHORS: KAIS A. RONA1 ¿ JAMES M. TATUM1 ¿ JOERG ZEHETNER3 ¿ KATRIN SCHWAMEIS1 ¿ CAROL CHOW2 ¿ KAMRAN SAMAKAR, ADRIAN DOBROWOLSKY ¿ CAITLIN C. HOUGHTON ¿ NIKOLAI BILDZUKEWICZ ¿ JOHN C. LIPHAM. CITATION: SURGICAL ENDOSCOPY (2018) 32:3374¿3379; HTTPS://DOI.ORG/10.1007/S00464-018-6059-6. THIS RETROSPECTIVE COHORT STUDY REPORTS INTERMEDIATE-TERM OUTCOMES AND HERNIA RECURRENCE RATE AFTER CONCOMITANT MSA AND HHR. BETWEEN MAY 2009 AND DECEMBER 2015, 53 PATIENTS (AGE RANGE 40 ¿ 79 YEARS, MEAN AGE 62.8 YEARS; GENDER RATIO F:M REPORTED AS 1.84:1; MEAN BMI 25.6 ± 7.5) UNDERWENT MSA IMPLANTATION WITH THE LINX REFLUX MANAGEMENT SYSTEM (ETHICON) AND REPAIR OF A HIATAL HERNIA MEASURING AT LEAST 3 CM. HIATUS. ONCE THE HIATAL REPAIR WAS COMPLETED, THE EXTERNAL CIRCUMFERENCE OF THE GASTROESOPHAGEAL JUNCTION WAS MEASURED AND AN APPROPRIATELY SIZED LINX DEVICE PLACED. REPORTED COMPLICATIONS INCLUDED MILD (GRADE A OR B) ESOPHAGITIS (N=5.6%); AND MALPOSITIONED MSA DEVICE (N=1). THE MSA DEVICE WAS THEN REMOVED AND A CONVERSION TO A TOUPET FUNDOPLICATION WAS PERFORMED. IN CONCLUSION, CONCOMITANT MAGNETIC SPHINCTER AUGMENTATION AND HIATAL HERNIA REPAIR IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE AND A MODERATE-SIZED HIATAL HERNIA DEMONSTRATES DURABLE SUBJECTIVE REFLUX CONTROL AND AN ACCEPTABLE HIATAL HERNIA RECURRENCE RATE AT 1- TO 2-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934457 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1