BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 13313894 · Received January 21, 2022

    Report

    Report Number
    3008766073-2022-00012
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    August 30, 2021
    Report Date
    January 21, 2022
    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 · 0

    (B)(4). 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.

    Description of Event or Problem · 0

    TITLE: MAGNETIC SPHINCTER AUGMENTATION DEVICE REMOVAL: SURGICAL TECHNIQUE AND RESULTS AT MEDIUM-TERM FOLLOW-UP. AUTHOR/S: DAVIDE BONA, GRETA SAINO, EMANUELE MINI, FRANCESCA LOMBARDO, VALERIO PANIZZO, MARTA CAVALLI, GIANLUCA BONITT, GIAMPIERO CAMPANELLI2, ALBERTO AIOLFI. CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2021) 406:2545¿2551. HTTPS://DOI.ORG/10.1007/S00423-021-02294-71. THE PURPOSE OF THIS SINGLE-CENTER COHORT STUDY WAS TO ANALYZE OUR EXPERIENCE WITH MSA REMOVAL AND DESCRIBE THE SURGICAL TECHNIQUE, INTRAOPERATIVE TECHNICAL ASPECTS, AND MEDIUM-TERM FOLLOW-UP RESULTS. DURING THE STUDY PERIOD, 32 MSA DEVICES WERE IMPLANTED AT OUR INSTITUTION AND FIVE PATIENTS UNDERWENT MSA EXPLANT. FOUR PATIENTS WERE MALES AND THE MEDIAN AGE WAS 47 YEARS (RANGE 44¿55). THE MEDIAN BODY MASS INDEX (BMI) WAS 23.1 KG/M2 (RANGE 20.9¿24.3). THE MEDIAN IMPLANT DURATION WAS 46 MONTHS (RANGE 31¿72). ALL PATIENTS UNDERWENT A SINGLE-STAGE LAPAROSCOPIC REMOVAL WITH INTRAOPERATIVE ENDOSCOPIC ASSISTANCE. THE MOST COMMON ANTI-REFLUX PROCEDURE PERFORMED IN CONJUNCTION WITH MSA DEVICE REMOVAL WAS AN ANTERIOR DOR FUNDOPLICATION (DF) (N = 2) FOLLOWED BY TOUPET FUNDOPLICATION (TF) AND CRURAL REPAIR (N = 2). IN THE PATIENT THAT EXPERIENCED MSA EROSION, AN ANTERIOR PARTIAL FUNDOPLICATION WAS PERFORMED (N = 1) AFTER REMOVAL. A (B)(6) MALE PATIENT EXPERIENCED RECURRENT HEARTBURN AND CHEST PAIN. A (B)(6) FEMALE PATIENT EXPERIENCED DYSPHAGIA, CHEST PAIN AND EROSION. A (B)(6) MALE PATIENT EXPERIENCED DYSPHAGIA. A (B)(6) MALE PATIENT EXPERIENCED RECURRENT HEARTBURN, EPIGASTRIC PAIN AND REGURGITATION. A (B)(6) MALE PATIENT EXPERIENCED RECURRENT HEARTBURN AND REGURGITATION. THE MEDIAN POSTOPERATIVE FOLLOW-UP WAS 41 MONTHS (RANGE 12¿51). AT THE LAST FOLLOW-UP, THE MEDIAN GERDHRQL WAS SIGNIFICANTLY IMPROVED COMPARED TO PREOPERATIVE DATA (6 ± 1.8 VS. 24 ± 9.3; P < 0.05), 80% OF PATIENTS WERE OFF PPI, AND PATIENTS¿ QUALITY OF LIFE ASSESSED WITH THE SF-36 QUESTIONNAIRE WAS IMPROVED. IN CONCLUSION, THE MSA DEVICE CAN BE SAFELY EXPLANTED THROUGH A SINGLE-STAGE LAPAROSCOPIC PROCEDURE. TAILORING A FUNDOPLICATION, ACCORDING TO PREOPERATIVE PATIENT SYMPTOMS AND INTRAOPERATIVE FINDINGS, SEEMS FEASIBLE AND SAFE WITH A PROMISING TREND TOWARD IMPROVED SYMPTOMS AND QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960658 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention