BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 12391386 · Received August 31, 2021

    Report

    Report Number
    3008766073-2021-00177
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 26, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: HOW WAS THE MIGRATION OF THE DEVICE DIAGNOSED (CHEST X-RAY, ESOPHAGEAL LINE AT EXPLANT)? ENDOSCOPY. ARE THERE IMAGES AVAILABLE THAT SHOWS THE MIGRATION? YES. DID THE PATIENT HAVE A HIATAL HERNIA AT THE TIME OF IMPLANT? IF YES WAS THIS REPAIRED AT THIS TIME OF IMPLANT? YES, IT WAS REPAIRED AT THE TIME OF IMPLANTATION. DOES THE PATIENT HAVE A RE-OCCURRING HERNIA NOW? IF YES, DID THE POSITION OF THE DEVICE CHANGE BASED ON THE HERNIA REOCCURRING? THE PATIENT DOESN´T HAVE RE-OCCURRING HIATAL HERNIA. WHAT CLINICAL SYMPTOMS DID THE PATIENT HAVE THAT LEAD TO THE DISCOVERY OF THE MIGRATED DEVICE? DYSPHAGIA. WHEN IS THE EXPLANT SURGERY PLANNED? (B)(6) 2021. WILL THE DEVICE BE RETURNING FOR ANALYSIS? NO. PHOTO WAS PROVIDED FOR REVIEW BY ETHICON MEDICAL SAFETY OFFICER. FOLLOWING ARE THEIR OBSERVATIONS: I REVIEWED THREE PHOTOGRAPHS SHOWING UPPER ENDOSCOPIC IMAGES OF THE PATIENT¿S ESOPHAGUS ASSOCIATED WITH THIS COMPLAINT. THE IMAGES SHOWED AN EROSION OF THE LINX DEVICE INTO THE LUMEN OF THE STOMACH. TWO LINX BEADS WERE VISIBLE AT THE GEJ. ADDITIONAL INFORMATION FROM MEDICAL SAFETY OFFICER: THERE IS NO MIGRATION. THE DEVICE LOOKS LIKE IT IS THE PROPER LOCATION FROM THE PHOTOS.

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY EVENT YEAR KNOWN: 2021. NO LOT NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. 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: HOW WAS THE MIGRATION OF THE DEVICE DIAGNOSED (CHEST X-RAY, ESOPHAGEAL LINE AT EXPLANT)? ARE THERE IMAGES AVAILABLE THAT SHOWS THE MIGRATION? DID THE PATIENT HAVE A HIATAL HERNIA AT THE TIME OF IMPLANT? IF YES WAS THIS REPAIRED AT THIS TIME OF IMPLANT? DOES THE PATIENT HAVE A RE-OCCURRING HERNIA NOW? IF YES, DID THE POSITION OF THE DEVICE CHANGE BASED ON THE HERNIA REOCCURRING? WHAT CLINICAL SYMPTOMS DID THE PATIENT HAVE THAT LEAD TO THE DISCOVERY OF THE MIGRATED DEVICE? WHEN IS THE EXPLANT SURGERY PLANNED? WILL THE DEVICE BE RETURNING FOR ANALYSIS? WHAT IS THE PRODUCT CODE? WHAT IS THE LOT NUMBER OF THE PRODUCT? WHAT IS THE IMPLANT DATE? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LINX IMPLANT HAS MIGRATED. EXPLANT IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300284 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention