BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 14B

    MDR report key: 8671534 · Received June 5, 2019

    Report

    Report Number
    3008766073-2019-00356
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 9, 2019
    Report Date
    May 14, 2019
    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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE ANALYSIS: 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. OVERALL, NO ANALYSIS CONCLUSIONS RELEVANT TO THE PATIENT EXPERIENCE WERE FOUND. THE DHR OF LOT 10458 WAS REVIEWED. NO NCS, REWORKS, OR DEFECTS WERE FOUND. NOTE: LOT 10458 IS THE LOT NUMBER CORRESPONDING TO SERIAL NO. (B)(6) (THE REPORTED LOT NUMBER WAS INVALID). THE PRODUCT CODE OF LOT 10458 (LXMC14) MATCHES THE REPORTED PRODUCT CODE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE EVENT SPEAKS OF ¿MULTIPLE INTERVENTIONS¿, WHAT WERE THEY? DILATION X2 WITH FOOD IMPACTION ¿ LOOKS LIKE THERE WERE IN 2016. HE DID HAVE ENDOSCOPIES AND BA SWALLOW LATER WHICH WERE UNREMARKABLE. WHAT IS THE LOT AND SERIAL NUMBER FOR THE LXMC14? LOT # 10018896 ¿ SERIAL # (B)(4). DID THE PATIENT HAVE AN AUTOIMMUNE DISEASE? NO. IS THE PATIENT CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? NO. DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? YES - ELEVATION OF IRP - ¿THERE APPEARS TO BE PRESSURIZATION, WHICH IS CREATED BY RESISTANCE TO ESOPHAGEAL EMPTYING¿. HOW SEVERE WAS THE DYSPHAGIA/ODYNOPHAGIA BEFORE INTERVENTION? DYSPHAGIA WAS HIS PRIMARY PRESENTING SYMPTOM. ¿WHEN HE EATS HE FEELS LIKE HIS THROAT IS CLOSING. REPORTS IT IS DIFFICULT TO SWALLOW WHICH OCCURS WITH SOLIDS AND HOT LIQUIDS¿. DID THE DYSPHAGIA IMPROVE AFTER THE DEVICE WAS IMPLANTED INITIALLY? NO. WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? NONE IDENTIFIED. WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? YES, CRURAL REPAIR AND 5 CM HERNIA REPAIR. WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE REPORTED DYSPHAGIA/ODYNOPHAGIA? NO. WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF LXMC14, ONGOING DYSPHAGIA AND ODYNOPHAGIA DESPITE MULTIPLE INTERVENTIONS, THE ISSUE WAS RESOLVED WITH EXPLANT, UNKNOWN HOW THE PATIENT IS DOING POST EXPLANT. THE EXPLANT WAS NOT INITIALLY IMPLANTED AS THE SAME SITE. THEY HAVE REQUESTED MEDICAL RECORDS FROM THE IMPLANT SITE, BUT NO ASSURANCES IT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466021 1.5T LINX, 14B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. 10018896 00855106005349

    Patients

    Seq Age Sex Outcome Treatment
    1