BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 17 BEADS

    MDR report key: 9903941 · Received March 31, 2020

    Report

    Report Number
    3008766073-2020-00060
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    February 8, 2020
    Report Date
    March 11, 2020
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005370
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 04/09/2020. ADDITIONAL INFORMATION RECEIVED: REPORTS CT ABD PELVIS W/CONTRAST, ER VISIT , CT ANGIO CHEST. MEDICAL REVIEW PER MEDICAL SAFETY OFFICER - I REVIEWED THE MEDICAL RECORDS ASSOCIATED WITH (B)(4). THERE IS NO CORRELATION OF THE SYMPTOMS AND RADIOLOGY REPORTS TO ANY SPECIFIC DIAGNOSIS. THE SYMPTOMS ARE ATYPICAL FOR A PATIENT FOLLOWING LINX IMPLANTATION AND AT THIS POINT IN TIME ARE NOT CONSISTENT WITH ANY ASSOCIATION TO THE LINX DEVICE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 04/09/2020. ADDITIONAL INFORMATION RECEIVED: CLINIC VISIT, CT HEAD REPORT

    Additional Manufacturer Narrative · 0

    (B)(4). NEW INFORMATION RECEIVED: HYCOSAMINE DIDN'T HELP; AMITRYPTILINE STARTED & HAS HELPED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 04/03/2020. THE DHR FOR LOT: 25798 WAS REVIEWED. NO NCS, DEFECTS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 03/31/2020. DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS THE INTERNAL MEDICINE DOCTOR¿S DIAGNOSIS OF THE CURRENT SYMPTOMS? RESPONSE: (B)(6) 2020: CLINIC VISIT REFLUX HAD RESOLVED. PLAN TO WEAN OFF PPI. 3/26/20: SC SPOKE W/SUBJECT. FACE TINGLING AND PAIN STOPPED (B)(6) 2020. ESOPH SPASMS 80% BETTER AFTER MEDROL PACK COMPLETE, (B)(6) 2020. UNSUCCESSFUL WEANING FROM PPI. NOW ON 20 OMEPRAZOLE QD W/ACCEPTABLE SYMPTOM CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ON (B)(6) 2020 - ER VISIT FOR FACIAL PAIN, HEADACHE AND NAUSEA/VOMITING/DIARRHEA. LAB WORK AND X-RAYS DONE WITH NO CONCERNING FINDINGS. TREATED W/PAIN MEDS AND ORAL STEROIDS. SUBJECT HAD LINX IMPLANT (B)(6) 2020. ON 2/11/2020 - SUBJECT SPOKE WITH PI. SYMPTOMS HAD IMPROVED BUT STILL WITH FACIAL PAIN AND ESOPHAGEAL SPASMS. PI PRESCRIBED HYCOSAMINE. (B)(6) 2020 - CLINIC VS. FACIAL PAIN/ESOPHAGEAL SPASMS ONLY WHEN LYING DOWN NOW. PI PRESCRIBED STEROIDS. SPECIFY MEDICATION: HYDROCODONE/ACETAMINOPHEN, PREDNISONE, HYCOSAMINE. UPDATED TO: TORODOL, BENADRYL, PREDNISONE, ZOFRAN, COMPAZINE - TORODOL, MORPHINE, BENADRYL, PREDNISONE, ZOFRAN, COMPAZINE, HYCOSAMINE. HOSPITALIZATION: NO. DYSPHAGIA - RECURRENCE/PATTERN: CONTINUOUS- SUBJECT STAYED ON PRE-OP OMEPRAZOLE POST- LINX IMPLANT. AT 2 WEEK F/U VISIT ON (B)(6) 2020 SUBJECT WAS HAVING NO REFLUX SYMPTOMS SO PI HAD HER DISCONTINUE. SUBJECT CONTINUED TO EXPERIENCE HEARTBURN AND EPIGASTRIC PAIN SO ON (B)(6) 2020 RESUMED TAKING OMEPRAZOLE. AT CLINIC VISIT ON (B)(6) 2020, SUBJECT'S REFLUX HAD RESOLVED. PI MOVED OMEPRAZOLE DOSING TO EVENING WITH PLANS TO EVENTUALLY WEAN OFF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367188 1.5T LINX, 17 BEADS ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC17 25798 00855106005370

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention