BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 15B

    MDR report key: 15198437 · Received August 10, 2022

    Report

    Report Number
    3008766073-2022-00158
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    January 1, 2022
    Report Date
    November 28, 2022
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005356
    PMA / PMN Number
    P100049
    Removal / Correction Number
    Z-2038-2018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EVENT DATE: ONLY EVENT YEAR KNOWN: 2022. LOT NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. LINX PHOTO IMAGES WERE RECEIVED AND ARE PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT SYMPTOMS LEAD TO THE DISCOVERY OF THE DISCONTINUOUS DEVICE? VOMITING, EPIGASTRIC PAIN. WHEN DID THE SYMPTOMS BEGIN? SHORTLY AFTER LINX PLACEMENT IN 2017. WHAT WAS THE DATE OF THE LINX IMPLANT PROCEDURE? ON (B)(6) 2017. WHAT IS THE DEVICE LOT AND SERIAL NUMBER? LOT 15314. WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? YES. WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? VOMITING. DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? IF SO, WHEN WAS THE MRI AND WHAT STRENGTH? NO. DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? NO. WAS ANY ADDITIONAL IMAGING PERFORMED SINCE DEVICE IMPLANT? DOES THE DEVICE APPEAR TO BE IN A CONTINUOUS ANNULAR STATE IN THESE IMAGES? WE ARE INTERESTED IN ESTABLISHING A WINDOW WHEN THE DEVICE MAY HAVE BECOME DISCONTINUOUS. PLEASE SHARE ANY ADDITIONAL IMAGES. YES-UPPER GI (B)(6) 2017, EGD BRAVO (B)(6) 2017, UPPER GI (B)(6) 2017 AND EGD BRAVO (B)(6) 2022. IS THE EXPLANT PROCEDURE SCHEDULED? IS A REPLACEMENT LINX OR FUNDOPLICATION PLANNED? NOT YET. YES PLAN IS TO REPLACE. FEMALE DOB 2/26/1941. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4); DATE SENT: 11/1/2022.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/19/2022. PHOTO ANALYSIS: AN X-RAY IMAGE OF THE DEVICE IN VIVO WAS REVIEWED BY A MEDICAL SAFETY OFFICER. AS PER MEDICAL SAFETY OFFICER: DEVICE APPEARS TO BE DISCONTINUOUS AND IS LOCATED BELOW THE DIAPHRAGM. THE MECHANISM/CAUSE OF FAILURE CANNOT BE DETERMINED FROM THE PROVIDED IMAGES. LOT 15314 WAS AN AFFECTED LOT OF THE 2018 LINX RECALL. ADDITIONAL INFORMATION RECEIVED: THE LOT NUMBER SHOULD BE FOR A LXMC15.

    Additional Manufacturer Narrative · 0

    (B)(4).DATE SENT: 11/28/2022INVESTIGATION SUMMARYA LINX DEVICE WITH A VISIBLE WELD BALL THAT DISCONNECTED FROM A WASHER WAS RETURNED TO THE ANALYSIS SITE. THE LINK LENGTH AND TENSILE FORCE MEASUREMENTS WERE FOUND TO MEET THE APPLICABLE SPECIFICATIONS DURING DEVICE ANALYSIS. THE REMAINING DEVICE CHARACTERISTICS, EXCEPTING THE VISIBLE WELD BALL, SHOW NO ANOMALIES FOR A DEVICE THAT HAS BEEN REASONABLY CHANGED AS PART OF THE EXPLANT PROCEDURE. THE DEVICE WAS SCANNED USING COMPUTER TOMOGRAPHY (CT), OPTICAL MICROSCOPY, AND SCANNING ELECTRON MICROSCOPY.THE WASHER THROUGH-HOLE AT THE SEPARATION WAS MEASURED AND WAS GREATER THAN THE SPECIFICATION. THE WASHER THROUGH-HOLE WAS CONCENTRIC WITH SMALL AMOUNT OF MATERIAL DISPLACEMENT AT THE OUTER EDGE OF THE THROUGH HOLE. THE OVERALL APPEARANCE OF THE SURFACE OF THE WASHER THROUGH HOLE DIDN¿T EXHIBIT GROSS LOSS OF SHAPE.THE TOP VIEW OF THE DIAMETER OF THE EXPOSED WELD BALL WAS MEASURED. THIS DIAMETER IS WITHIN THE SPECIFICATION. THE WELD BALL WAS CONCENTRIC WITH THE RESPECT TO THE WIRE.A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 15314, AND NO RELATED NONCONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LINX DEVICE WAS REPORTED AS DISCONTINUOUS AND CONFIRMED WITH UNKNOWN DIAGNOSTICS. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399283 1.5T LINX, 15B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC16 15314 00855106005356

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention