BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 17247899 · Received July 3, 2023

    Report

    Report Number
    3008766073-2023-00130
    Event Type
    Injury
    Date Received
    July 3, 2023
    Date of Event
    February 15, 2022
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/3/2023. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH 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: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    TITLE: IMPEDANCE PLANIMETRY (ENDOFLIP¿) AFTER MAGNETIC SPHINCTER AUGMENTATION (LINX®) COMPARED TO FUNDOPLICATION. AUTHORS: HOOVER WU, MIKHAIL ATTAAR, HARRY J. WONG, MICHELLE CAMPBELL, KRISTINE KUCHTA, WOODY DENHAM, JOHN LINN, MICHAEL B. UJIKI. CITATION CITE: SURGICAL ENDOSCOPY (2022) 36:7709¿7716. HTTPS://DOI.ORG/10.1007/S00464-022-09128-7. THE RETROSPECTIVE STUDY AIMS TO REPORT THE INSTITUTIONAL EXPERIENCE IN PERFORMING FUNCTIONAL LUMINAL IMAGING PROBE (FLIP) DURING MAGNETIC SPHINCTER AUGMENTATION (MSA) AND TO COMPARE THESE MEASUREMENTS TO THOSE OBTAINED DURING NISSEN AND TOUPET FUNDOPLICATION. FROM AUGUST 2018 TO JUNE 2021, 27 PATIENTS (11 ARE MALES, AGE [MEAN ± SD]: 56 ± 11, BODY MASS INDEX [MEAN ± SD]: 29.4 ± 4.6) HAD MSA AND INTRAOPERATIVE FLIP EVALUATIONS. ONE HUNDRED PATIENTS HAD FUNDOPLICATION (66 TOUPET AND 34 NISSEN) AND INTRAOPERATIVE FLIP WITHIN THE SAME TIMEFRAME. FLIP MEASUREMENTS AT THE GASTROESOPHAGEAL JUNCTION (GEJ) WERE RECORDED WITHOUT PNEUMOPERITONEUM AT 40 ML BALLOON FILL AFTER HERNIA REDUCTION, CRUROPLASTY, AND MSA OR FUNDOPLICATION. REFLUX SYMPTOM INDEX (RSI), GERD-HRQL, AND DYSPHAGIA SCORE WERE COLLECTED UP TO 2 YEARS. ENDOFLIP UNIT 1.0 AND 8 CM CATHETER (EF-325) WAS USED FOR FUNCTIONAL LUMINAL IMAGING PROBE AND LINX WAS USED IN MSA IN THE STUDY. COMPLICATIONS INCLUDE 30-DAY POST OPERATIVE COMPLICATION. IN CONCLUSION, INTRAOPERATIVE IMPEDANCE PLANIMETRY PROVIDED OBJECTIVE INFORMATION REGARDING THE GEOMETRY OF THE GEJ DURING MSA. THE RING OF MAGNETIC BEADS RESTORES THE ANTI-REFLUX BARRIER AND TRANSIENTLY OPENS WITH FOOD BOLUS AND BELCHING. THE MAGNETIC FORCE OF THE BEADS MAY EXPLAIN WHY THE DISTENSIBILITY INDEX (DI) AFTER MSA IS LOWER YET POSTOPERATIVE QUALITY OF LIFE IS NO DIFFERENT THAN NISSEN FUNDOPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253780 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R