BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 11585196 · Received March 29, 2021

    Report

    Report Number
    3008766073-2021-00061
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    November 14, 2019
    Report Date
    March 11, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2019. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WAS THE MSA DEVICE USED IN THIS JOURNAL ARTICLE THE TORAX LINX DEVICE BY ETHICON? IN THE JOURNAL ARTICLE IT STATES PATIENT WERE ON PPI WHILE THE MSA WAS IMPLANTED. WAS THE PPI OVER THE COUNTER? WAS THE PPI DOCTOR PRESCRIBED? WHAT IS MEANT BY ¿BREAKTHROUGH SYMPTOMS¿? PLEASE BE VERY SPECIFIC ON WHAT SYMPTOMS EACH PATIENT WAS HAVING WHILE THE TORAX LINX DEVICE BY ETHICON WAS IMPLANTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: MAGNETIC SPHINCTER AUGMENTATION IS AN EFFECTIVE TREATMENT FOR ATYPICAL SYMPTOMS CAUSED BY GASTROESOPHAGEAL REFLUX DISEASE. AUTHORS: MARC A. WARD, AHMED EBRAHIM, JEFFREY KOPITA, LINDSAY ARVISO, GERALD O. OGOLA, BRITTANY BUCKMASTER, STEVEN G. LEEDS. CITATION: SURGICAL ENDOSCOPY (2020); 34:4909¿4915. DOI: HTTPS://DOI.ORG/10.1007/S00464-019-07278-9 THE PURPOSE OF THIS RETROSPECTIVE REVIEW OF A PROSPECTIVELY MAINTAINED INSTITUTIONAL REVIEW BOARD-APPROVED DATABASE STUDY WAS TO DETERMINE WHETHER MSA COULD EFFECTIVELY TREAT PATIENTS WITH GERD WHO SUFFER FROM ATYPICAL SYMPTOMS, WHETHER TYPICAL SYMPTOMS WERE ALSO PRESENT OR NOT. BETWEEN JANUARY 2015 AND DECEMBER 2018, A TOTAL OF 86 PATIENTS (38 MALES; 48 FEMALES; MEDIAN AGE = 51.5 YEARS) DIAGNOSED AND CONFIRMED TO HAVE GERD, UNDERWENT MSA IMPLANTATION. REPORTED COMPLICATIONS INCLUDED DISSATISFIED WITH MSA (N=8) AND WERE INVITED TO UNDERGO A COMPREHENSIVE ESOPHAGEAL WORKUP. ALL PATIENTS HAD NORMALIZATION OF THEIR DEMEESTER SCORE PER 48-H BRAVO OFF ANTI-REFLUX MEDICATION. INTERMITTENT DYSPHAGIA WAS THE PRIMARY COMPLAINT IN THESE PATIENTS. THREE WERE TREATED WITH ENDOSCOPIC DILATION OF THE MSA AND FIVE REQUIRED THE DEVICE TO BE EXPLANTED. AT 1 YEAR FOLLOW UP, 9% OF PATIENTS WERE STILL ON PPI TO TREAT BREAKTHROUGH SYMPTOMS. IN CONCLUSION, MSA IS AN EFFECTIVE TREATMENT FOR TYPICAL AND ATYPICAL GERD SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480942 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention