BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9103815 · Received September 23, 2019

    Report

    Report Number
    3008766073-2019-00469
    Event Type
    Injury
    Date Received
    September 23, 2019
    Report Date
    August 28, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 09/23/2019. 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: ESOPHAGEAL SPHINCTER DEVICE/ ANTIREFLUX SURGERY: WHO NEEDS IT? AUTHORS: GANZ RA; PETERS J; HORGAN S; NUZHAT A. AHMAD; JOSEPH ANDERSON; DARREN M. BRENNER; ANDREW T. CHAN; FRANCIS K. L. CHAN; LIN CHANG; TSUTOMU CHIBA; MASSIMO COLOMBO; B. JOSEPH ELMUNZER; ALEX FORD; TIMOTHY B. GARDNER; LAUREN B. GERSON; W. RAY KIM; PAUL Y. KWO; JOSEP M. LLOVET; EDWARD V. LOFTUS; JULIAN PANES; LAURENT PEYRIN- BIROULET; JOEL H. RUBENSTEIN; SAMEER SAINI; SHIV K. SARIN; SHAMITA B. SHAH; PRATIMA SHARMA; AMIT SINGAL; JAN TACK; AKBAR WALJEE; KENNETH K. WANG; ALASTAIR J. M. WATSON. CITATION: ESOPHAGEAL SPHINCTER DEVICE FOR GASTROESOPHAGEAL REFLUX DISEASE. N ENGL J MED 2013; 368; 8:719¿727. THE OBJECTIVE OF THE PROSPECTIVE, MULTICENTER, SINGLE-GROUP STUDY WAS TO EVALUATE SAFETY, EFFICACY, AND DIRECT EFFECTS OF THE DEVICE ON EXPOSURE TO ESOPHAGEAL ACID, QUALITY OF LIFE, AND THE USE OF PROTON PUMP INHIBITORS (PPIS). THE AUTHORS PERFORMED A 5-YEAR PROSPECTIVE, MULTICENTER, SINGLE-GROUP EVALUATION OF MAGNETIC SPHINCTER DEVICE IN PATIENTS, AGE RANGE BETWEEN 18 AND 75 YEARS WITH A = 6-MONTH HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), PARTIAL RESPONSE TO DAILY PPIS, AND INCREASED EXPOSURE TO ACID ON PH MONITORING. DATA WERE AVAILABLE FOR 98 PATIENTS AT YEAR 1. THE AUTHORS REPORTED THAT THE LOWER ESOPHAGEAL SPHINCTER AUGMENTATION WITH A MAGNETIC DEVICE MAY PROVIDE AN ALTERNATIVE TREATMENT FOR PATIENTS WITH INCOMPLETE SYMPTOMATIC RELIEF WITH PPI OR RELUCTANCE TO UNDERGO FUNDOPLICATION. REPORTED COMPLICATIONS INCLUDED SERIOUS ADVERSE EVENTS (N=6) WHICH REQUIRED REMOVAL OF THE DEVICE DURING THE 3-YEAR FOLLOW-UP; DYSPHAGIA (N=68%) WHICH GRADUALLY REDUCED WITH TIME WITH A SIGNIFICANT NUMBER OF PATIENTS REQUIRING REPEATED ESOPHAGEAL DILATIONS; DE NOVO ESOPHAGITIS (N=?) WHICH WAS DEVELOPED TO SEVERAL PATIENTS WITH MILD GRADES AND 1 PATIENT DEVELOPED GRADE D BUT WAS COMPLETELY ASYMPTOMATIC. IN CONCLUSION, THE CLINICAL DATA CLEARLY SHOWED THAT THE PATIENTS HAD HEARTBURN SYMPTOMS DESPITE PPI THERAPY, WHICH RESOLVED AFTER MAGNETIC AUGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896291 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1