BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX 1.5T 15 BEAD OUS

    MDR report key: 12704103 · Received October 27, 2021

    Report

    Report Number
    3008766073-2021-00216
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    September 18, 2021
    Report Date
    August 15, 2022
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    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: 5/10/2022. ADDITIONAL INFORMATION RECEIVED: DESCRIBE THE TECHNIQUE USED FOR EXPLANT (CHECK ALL THAT APPLY). LAPAROSCOPIC: NO. ENDOSCOPIC: NO. OTHER: YES. DESCRIBE ANY NOTABLE OBSERVATIONS DURING THE EXPLANT PROCEDURE: LINX DEVICE IN SITU WITH DENSE ADHESIONS AROUND THE GEJ. CUFF OF THE HIATUS WAS EXCISED WITH THE LINX DEVICE TO ENCIRCLE THE CARDIA. ADVERSE EVENT TERM: OESOPHAGEAL CANCER REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES. ADMISSION DATE: ON (B)(6) 2022 RESULTED IN MEDICAL OR SURGICAL INTERVENTION: YES. RELATIONSHIP TO STUDY DEVICE: NOT RELATED. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: NOT RELATED. LINX EXPLANT: YES. OTHER SURGICAL INTERVENTION: YES. AWARENESS DATE : 07 APR 2022 / 22 APR 2022. START DATE: ON (B)(6) 2022 / ON (B)(6) 2022. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE EXACT DATE OF THE EXPLANT PROCEDURE? ON (B)(6) 2022. PARTICIPANT HAD ANXIETY ABOUT IMPLANT. NO MESH WAS USED AT TIME OF IMPLANT. 4CM HERNIA PRESENT AT TIME OF IMPLANT. POST IMPLANT: DIFFICULTY SWALLOWING: TRUE. PAINFUL SWALLOWING: TRUE. EMERGENCY ROOM: TRUE 1 VISIT. HOSPITAL STAY GREATER THAN 24 HOURS: TRUE. IDENTIFY THE NUMBER OF TIMES YOU VISITED HOSPITAL STAY GREATER THAN 24 HOURS? 1. HAS THE PARTICIPANT UNDERGONE A LINX EXPLANT? YES. HAS THE PARTICIPANT UNDERGONE A LINX RE-IMPLANT SURGERY? NO. LINX DEVICE IN SITU WITH DENSE ADHESIONS AROUND THE GEJ. CUFF OF THE HIATUS WAS EXCISED WITH THE LINX DEVICE TO ENCIRCLE THE CARDIA. ADVERSE EVENT TERM DYSPHAGIA AWARENESS DATE: 21 SEP 2021. START DATE: ON (B)(6) 2021. SEVERITY SEVERE. IS THE ADVERSE EVENT SERIOUS? (IF YES, CHECK ALL THAT APPLY) YES. REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: TRUE. ADMISSION DATE: ON (B)(6) 2021. DISCHARGE DATE: ON (B)(6) 2021 RELATIONSHIP TO STUDY DEVICE CAUSAL RELATIONSHIP. DILATION PERFORMED: FALSE. DRUG THERAPY (PRESCRIPTION): TRUE. ADVERSE EVENT TERM DYSPHAGIA. AWARENESS DATE: 26 FEB 2022. START DATE: ON (B)(6) 2022. SEVERITY MILD. ADVERSE EVENT TERM OESOPHAGEAL CANCER AWARENESS DATE: 22 APR 2022. START DATE: ON (B)(6) 2022 SEVERE. REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: TRUE. ADMISSION DATE: ON (B)(6) 2022. NO DISCHARGE DATE. WERE THERE ANY PROTOCOL DEVIATIONS? YES. DATE OF DEVIATION: ON (B)(6) 2021. WHAT WAS THE PROTOCOL DEVIATION? AE/SAE REPORTING SAE WAS NOT REPORTED WITHIN THE STIPULATED TIMEFRAME IN THE PROTOCOL. SPONSOR ASSESSMENT OF DEVIATION MINOR NOTE BODY (LOCAL LANGUAGE). THE CANCER IS CERTAINLY NOT DEVICE OR PROCEDURE RELATED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/12/2022. ADDITIONAL INFORMATION PROVIDED: (THE ESOPHAGEAL CANCER IS) NEITHER PROCEDURE NOR DEVICE RELATED. IT¿S AN UNDERLYING CONDITION AS A RESULT OF LONGSTANDING GERD.

    Additional Manufacturer Narrative · 0

    (B)(4), DATE SENT: 8/15/2022. ADDITIONAL INFORMATION RECEIVED: REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES, ADMISSION DATE: (B)(6) 2021, DISCHARGE DATE: (B)(6) 2021, RELATIONSHIP TO STUDY DEVICE: POSSIBLE, RELATIONSHIP TO PRIMARY STUDY PROCEDURE: NOT RELATED, OTHER INTERVENTION/TREATMENT: YES, IF OTHER SPECIFY: IV PREMIX 1.5L, IV NEXIUM 40MG OM, ANALGESIA. TRIAL OF STEROIDS AS ?INFLAMMATION RESULTING IN DYSPHAGIA - IV METHYLPRED 25MG.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/9/2022. ADDITIONAL INFORMATION RECEIVED: REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES. ADMISSION DATE: (B)(6) 2022. DISCHARGE DATE: (B)(6) 2022. RELATIONSHIP TO STUDY DEVICE: NOT RELATED. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: NOT RELATED. REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION : YES OR NO. IF EVENT IS SERIOUS AND DEVICE RELATED, ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED? : BLANK NO. F EVENT IS SERIOUS AND DEVICE RELATED, ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED? : NO = N/A.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 7/22/2022 ADDITIONAL INFORMATION RECEIVED: LAPAROSCOPIC: NO ENDOSCOPIC: NO OTHER: YES IF OTHER, SPECIFY: OPEN WERE ANY CONCOMITANT PROCEDURES PERFORMED?: YES

    Additional Manufacturer Narrative · 1

    (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. THE DHR FOR LOT 24626 WAS REVIEWED. NO NCS, DEFECTS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND. ADDITIONAL INFORMATION WAS OBTAINED: (B)(6), LOG LINE 1 - EVENT DESCRIPTION: DYSPHAGIA, SEX: FEMALE, AGE (AT TIME OF CONSENT): (B)(6) YEARS, SEVERITY: SEVERE, IS THE ADVERSE EVENT SERIOUS? YES, RELATIONSHIP WITH STUDY DEVICE: CAUSAL RELATIONSHIP, RELATIONSHIP WITH STUDY PROCEDURE: NOT RELATED, OUTCOME: RECOVERED/RESOLVED, DRUG THERAPY: YES. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DID THE SUBJECT REQUIRE ADDITIONAL MEDICAL TREATMENT FOR ISSUES WITH LINX DEVICE? IF YES, DESCRIBE THE MEDICAL TREATMENT PROVIDED: IF MEDICATIONS WERE PART OF THE MEDICAL TREATMENT, WERE THE MEDICATIONS PRESCRIPTION OR OVER THE COUNTER? COULD YOU PLEASE PROVIDE THE PRODUCT CODE AND LOT NUMBER? ANSWER = DESCRIBE THE MEDICAL TREATMENT PROVIDED: HOSPITAL ADMISSION; MEDICATION IF MEDICATIONS WERE PART OF THE MEDICAL TREATMENT, WERE THE MEDICATIONS PRESCRIPTION OR OVER THE COUNTER? PRESCRIPTION COULD YOU PLEASE PROVIDE THE PRODUCT CODE AND LOT NUMBER? PRODUCT CODE LXM 15, LOT NO: 24626. DATE OF SURGERY: (B)(6) 2021. REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES ADMISSION DATE: (B)(6) 2021 DISCHARGE DATE: (B)(6) 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6). EVENT: DYSPHAGIA. RELATIONSHIP TO STUDY DEVICE: CAUSAL RELATIONSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603669 LINX 1.5T 15 BEAD OUS ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. 24626

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization| R