BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 14B

    MDR report key: 12711625 · Received October 28, 2021

    Report

    Report Number
    3008766073-2021-00220
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 30, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005349
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/18/2021.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/30/2021. INVESTIGATION SUMMARY: OVERALL REVIEW OF THE DEVICE FUNCTION AND DIMENSIONS SHOW NO ANOMALIES FROM A DEVICE THAT HAS BEEN REASONABLY CHANGED AS PART OF THE EXPLANT PROCEDURE. VISUAL ANALYSIS WAS CONSISTENT WITH AN EXPLANTED DEVICE, AND LINK LENGTH AND TENSILE FORCE WERE FOUND TO MEET THE APPLICABLE SPECIFICATIONS. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT AS THE DEVICE IS FOUND TO MEET THE SPECIFICATIONS. OVERALL, NO ANALYSIS CONCLUSIONS RELEVANT TO THE PATIENT EXPERIENCE WERE FOUND.

    Additional Manufacturer Narrative · 0

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO LOT NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PRIOR TO LINX PLACEMENT, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? 3/4/21 PH: COMPOSITE DEMEESTER SCORE NORMAL AT 3.1 IN PROXIMAL SENSOR BUT DEMONSTRATES NUMEROUS EPISODES OF REFLUX THROUGHOUT THE DAY FROM 6AM-9PM; AET 5.2% 3/4/21 MANOMETRY: NORMAL LES RELAXATION WITH MEDIAN IRP 0.6 AND FRAGMENTED PERISTALSIS WITH DCI 677.0 MMHG-CM-S, MEAN WAVE AMPLITUDE 44.9 MMHG 1/21/21 EGD: 2CM HIATAL HERNIA, LA GRADE A ESOPHAGITIS, GASTRIC POLYP, GASTRITIS; PATHOLOGY NEGATIVE FOR INTESTINAL METAPLASIA; POSITIVE FOR ACTIVE ESOPHAGITIS. WHAT IS THE LOT NUMBER OF THE LINX DEVICE? - N/A. WHEN USING THE LINX SIZING DEVICE WHAT TECHNIQUE WAS USED TO DETERMINE THE SIZE? N/A. DID THE PATIENT HAVE AN AUTOIMMUNE DISEASE? N/A. IS THE PATIENT CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? NOT AT THIS TIME BUT SHE DID TRY PREDNISONE PRIOR TO EXPLANT. DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? N/A. HOW SEVERE WAS THE DYSPHAGIA/ODYNOPHAGIA BEFORE INTERVENTION? PRETTY SEVERE GIVEN WEIGHT LOSS OF 20+ LBS. WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? N/A. WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? N/A. WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE REPORTED DYSPHAGIA, NON-CARDIAC CHEST PAIN, REGURGITATION, WEIGHT LOSS, AND COUGHING? N/A. BESIDES THE REPORTED DYSPHAGIA NON-CARDIAC CHEST PAIN, REGURGITATION, WEIGHT LOSS, AND COUGHING., WHAT WAS THE REASON FOR REMOVAL OF THE LINX DEVICE? N/A. WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? PER EGD 9/20/21 LINX DEVICE IMPRESSION IN APPROPRIATE LOCATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED DUE TO DYSPHAGIA, NON-CARDIAC CHEST PAIN, REGURGITATION, WEIGHT LOSS, AND COUGHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608267 1.5T LINX, 14B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC14 00855106005349

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention