BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX 1.5 16 BEAD US

    MDR report key: 13003776 · Received December 14, 2021

    Report

    Report Number
    3008766073-2021-00261
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    June 17, 2021
    Report Date
    March 26, 2026
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    855106005363
    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: 1/27/2022. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 26705, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4); DATE SENT: 12/2/2022. ADDITIONAL INFORMATION RECEIVED: RELATIONSHIP TO STUDY DEVICE: UNLIKELY, RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE, DILATION PERFORMED: YES, INDICATE TYPE OF DILATION? MECHANICAL, DATE OF DILATION: (B)(6) 2021, DATE OF DILATION : (B)(6) 2021, START DATE : (B)(6) 2022 - (B)(6) 2021. RELATIONSHIP TO STUDY DEVICE: UNLIKELY, RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE, DILATION PERFORMED: YES, INDICATE TYPE OF DILATION? MECHANICAL, DATE OF DILATION: (B)(6) 2021, LINX EXPLANT: YES, LINX EXPLANT : NO -YES, START DATE : (B)(6) 2021 - (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 1/30/2024. ADDITIONAL INFORMATION RECEIVED: DATE OF DILATION : 24 OCT 2021 => 24 OCT 2022. UPDATED LOG LINE 1: AWARENESS DATE : 07 DEC 2022 => 01 DEC 2022. UPDATED LOG LINE 1: AWARENESS DATE : 17 JUN 2021 => 07 DEC 2022.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 3/26/2024 ADDITIONAL INFORMATION RECEIVED: START DATE : ON (B)(6) 2021 AND ON (B)(6) 2022. LOG LINE 1 UPDATED DATE OF DILATION : ON (B)(6) 2022 ,AND ON (B)(6) 2021, AWARENESS DATE : 01 DEC 2022 , 17 JUN 2021, START DATE : ON (B)(6) 2022 AND ON (B)(6) 2021. OUTCOME : NOT RECOVERED/NOT RESOLVED RECOVERED/RESOLVED ALERT DATE: ON (B)(6) 2024, DATE OF EXPLANT: ON (B)(6) 2022, COUNTRY OF EVENT: OUS, MODEL: LXMC16, DEVICE LOT NUMBER: 26705, DATE OF IMPLANT: ON (B)(6) 2021. PATIENT DETAILS PATIENT IDENTIFIER: (B)(6), SEX: FEMALE, AGE (AT TIME OF CONSENT): 55 YEARS. ADDITIONAL EVENT DETAILS WAS THE LINX EXPLANT A RESULT OF AN ADVERSE EVENT PER PROTOCOL DEFINITIONS?: YES IF YES, CHOOSE THE PRIMARY AE LOG LINE, START DATE AND TERM: #001 (B)(6) 2021-DYSPHAGIA IF NO, WHAT WAS THE REASON FOR THE EXPLANT? (CHECK ALL THAT APPLY) PARTICIPANT HAD ANXIETY ABOUT IMPLANT: NO MEDICAL NEED FOR HIGH FIELD STRENGTH MRI OR OTHER TESTING: NO PARTICIPANT WISHES TO HAVE ALTERNATIVE GERD TREATMENT REQUIRING LINX EXPLANT: NO CONTINUED GERD SYMPTOM: NO DID NOT MEET PARTICIPANT EXPECTATIONS: NO OTHER: NO IF OTHER, SPECIFY: BLANK DESCRIBE THE TECHNIQUE USED FOR EXPLANT (CHECK ALL THAT APPLY) LAPAROSCOPIC: NO ENDOSCOPIC: NO OTHER: YES IF OTHER, SPECIFY: UNKNOWN WERE ANY CONCOMITANT PROCEDURES PERFORMED?: NO DESCRIBE ANY NOTABLE OBSERVATIONS DURING THE EXPLANT PROCEDURE: UNKNOWN UPDATED EXPLANT NOTIFICATION: DATE OF LINX EXPLANT : ON (B)(6) 2022, END DATE : BLANK ON (B)(6) 2022. UPDATED LOG LINE 1: START DATE : ON (B)(6) 2021 .

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT:8/26/2024. CORRECTED DATA D4: UDI#.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/26/2026. ADDITIONAL INFORMATION: RELATIONSHIP TO STUDY DEVICE: UNLIKELY-POSSIBLE.

    Additional Manufacturer Narrative · 0

    (B)(4). 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. ADDITIONAL INFORMATION RECEIVED: MODEL: LXMC16 DEVICE LOT NUMBER: 26705 DATE OF SURGERY: (B)(6) 2021. PATIENT IDENTIFIER: (B)(6). INSTITUTE OF ESOPHAGEAL AND REFLUX SURGERY SEX: FEMALE AGE (AT TIME OF CONSENT): (B)(6). ADVERSE EVENT TERM: DYSPHAGIA. SITE AWARENESS DATE: (B)(6) 2021. SEVERITY: MODERATE. RELATIONSHIP TO STUDY DEVICE: UNLIKELY RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE IF RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO: INDEX INTERVENTION/TREATMENT: DILATION PERFORMED: YES. INDICATE TYPE OF DILATION? MECHANICAL. DATE OF DILATION: (B)(6) 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL TRIAL PATIENT EXPERIENCED DYSPHAGIA. THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193744 LINX 1.5 16 BEAD US ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC16 26705 855106005363

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention