BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LXC16

    MDR report key: 9072319 · Received September 16, 2019

    Report

    Report Number
    3008766073-2019-00453
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 20, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005172
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 FOR LOT 6275 WAS REVIEWED. NO NCS, DEFECTS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN, ASSUMED THE 1ST DAY OF MONTH THAT COMPLAINT WAS REPORTED. ADDITIONAL INFORMATION RECEIVED: 75 INCHES, (B)(6) LBS, 27.5 BMI. THERE WAS A HIATAL HERNIA REPAIR COMPLETED AT TIME OF IMPLANT. FIRST IMPLANT DONE ON (B)(6) 2015. BRAVO CAPSULE TEST ON (B)(6) 2015: HEARTBURN, CHEST PAIN, REGURGITATION, PAIN, BELCHING, BLOATING, GAS, DIARRHEA. PATIENT HAS HAD PERSISTENT REFLUX SINCE HIS INITIAL LINX SURGERY; SYMPTOMS HAD IMPROVED, REMAINED ON PPIS. HAD AN ENDOSCOPY AS PART OF PAS FOLLOW UP AND WAS FOUND TO HAVE AN ENLARGED HIATAL HERNIA. SURGEON DISCUSSED REPAIR OF THE HERNIA, THE PATIENT WANTED TO PROCEED. (B)(6).

    Description of Event or Problem · 1

    PATIENT HAD REPLACEMENT OF HIS LINX TODAY. THIS WAS A MINIMAL DISSECTION PROCEDURE INITIALLY AND DEVELOPED IN TO A PEH. TODAY THE PEH WAS REPAIRED. DR. WANTED IT NOTED THAT THE ONLY REASON TO REPLACE THE LINX WAS BECAUSE HE HAD A 1.5T DEVICE. LINX DEVICE EXPLANTED AND REPLACED WITH NEW LINX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862759 LXC16 ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. 6275 00855106005172

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR