BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9005851 · Received September 12, 2019

    Report

    Report Number
    3008766073-2019-00442
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. (B)(4). THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: SHORT-TERM OUTCOMES USING MAGNETIC SPHINCTER AUGMENTATION VERSUS NISSEN FUNDOPLICATION FOR MEDICALLY RESISTANT GASTROESOPHAGEAL REFLUX DISEASE. AUTHORS: BRIAN E. LOUIE, MD, ALEXANDER S. FARIVAR, MD, DALE SHULTZ, BS, CHRISTINA BRENNAN, CCRP, ERIC VALLIERES, MD, AND RALPH W. AYE, MD. CITATION: ANN THORAC SURG (2014); 98:498¿505. DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2014.04.074. THE AUTHORS EVALUATED THEIR EXPERIENCE WITH MAGNETIC SPHINCTER AUGMENTATION (MSA) AND COMPARED IT WITH LAPAROSCOPIC NISSEN FUNDOPLICATION (LNF) AT 6 MONTHS. A RETROSPECTIVE CASE-CONTROL STUDY WAS PERFORMED ON 34 CONSECUTIVE PATIENTS (MSA GROUP; 18 MALE AND 16 FEMALE; MEAN AGE:54 ±11.8 YEARS; BMI: 27 ±5.1 KG/M2) WHO UNDERWENT LAPAROSCOPIC IMPLANTATION OF A MAGNETIC SPHINCTER FOR CHRONIC GASTROINTESTINAL ESOPHAGEAL DISEASE (GERD) AND A HIATAL HERNIA OF LESS THAN 3 CM FROM SEPTEMBER 2012 TO DECEMBER 2013. FOR COMPARISON, A REVIEW OF 32 PATIENTS (LNF GROUP; 13 MALE AND 19 FEMALE; MEAN AGE: 47±12.2; BMI:30±4.4 KG/M2), WHO UNDERWENT LAPAROSCOPIC NISSEN FUNDOPLICATION (LNF), THAT WERE IDENTIFIED FROM A PROSPECTIVELY MAINTAINED BENIGN ESOPHAGEAL SURGICAL DATABASE FROM JANUARY 2010 TO JULY 2013. DURING LNF, ONCE A 3CM OF INTRAABDOMINAL ESOPHAGUS WAS ESTABLISHED, THE ESOPHAGEAL HIATUS WAS CLOSED WITH SINGLE ¿0¿ POLYESTER SUTURES (ETHICON). IN MAGNETIC SPHINCTER AUGMENTATION (MSA), THE APPROPRIATELY SIZED LINX DEVICE (ETHICON) WAS SITUATED IN THE TUNNEL AND AROUND THE ESOPHAGUS, AND THE SUTURES WERE SECURED USING A SUTURE-SECURING DEVICE. REPORTED COMPLICATIONS IN THE LNF GROUP INCLUDED ESOPHAGEAL OBSTRUCTION (N-1) IN WHICH A SUTURE WAS REMOVED FROM THE HIATAL CLOSURE AND WAS DISCHARGED WITHOUT FURTHER SEQUELAE, SWALLOWING ABILITY WORSENED AT 6 WEEKS (N-?), SYMPTOMATIC ESOPHAGEAL SPASMS (N-2) REQUIRING MEDICAL THERAPY, AND ESOPHAGITIS (N-1). REPORTED COMPLICATIONS IN THE MSA GROUP INCLUDED SWALLOWING ABILITY WORSENED AT 6 WEEKS (N-?), FOOD BOLUS IMPACTION (N-1) REQUIRING EVALUATION, BUT NO INVASIVE TREATMENT, DYSPHAGIA (N-1) IN WHICH THE PATIENT UNDERWENT ENDOSCOPIC BALLOON DILATION, ESOPHAGITIS WITH AN ELEVATED DEMEESTER SCORE (N-4), HEART BURN (N-3), REGURGITATAION (N-6), COUGH (N-27), ASPIRATION (N-28), AND CHEST PAIN (N-25). IN CONCLUSION, MSA RESULTS IN SIMILAR OBJECTIVE CONTROL OF GERD, SYMPTOM RESOLUTION, AND IMPROVED QUALITY OF LIFE COMPARED WITH LNF. MSA SEEMS TO RESTORE A MORE PHYSIOLOGIC SPHINCTER THAT ALLOWS PHYSIOLOGIC REFLUX, FACILITATES BELCHING, AND CREATES LESS BLOATING AND FLATULENCE. THIS DEVICE HAS THE POTENTIAL TO ALLOW INDIVIDUALIZED TREATMENT OF PATIENTS WITH GERD AND INCREASE THE SURGICAL TREATMENT OF GERD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801468 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1