BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 11348694 · Received February 19, 2021

    Report

    Report Number
    3008766073-2021-00030
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    January 28, 2021
    Report Date
    January 28, 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), DATE SENT: 3/23/2021, H6: C19. DEVICE ANALYSIS: OVERALL REVIEW OF THE DEVICE FUNCTION AND DIMENSIONS SHOW NO ANOMALIES FROM A DEVICE THAT HAS BEEN REASONABLY CHANGED AS PART OF THE EXPLANT PROCEDURE. VISUAL ANALYSIS WAS CONSISTENT WITH AN EXPLANTED DEVICE, AND LINK LENGTH AND TENSILE FORCE WERE FOUND TO MEET THE APPLICABLE SPECIFICATIONS. OVERALL, NO ANALYSIS CONCLUSIONS RELEVANT TO THE PATIENT EXPERIENCE WERE FOUND. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO LOT NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PRIOR TO LINX PLACEMENT, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? EGD: - NON-BLEEDING ESOPHAGEAL ULCERS. BIOPSIED. - SMALL HIATAL HERNIA. - NORMAL EXAMINED DUODENUM. - THE BRAVO PH CAPSULE WAS POSITIONED 28 CM FROM THE INCISORS, WHICH WAS 6 CM PROXIMAL TO THE GE JUNCTION. BIOPSIES: (GEJ) - SQUAMOUS EPITHELIUM WITH REACTIVE CHANGES AND ULCERATION WITH ASSOCIATED ACUTE INFLAMMATION. (GEJ) - NEGATIVE FOR DYSPLASIA AND MALIGNANCY (GEJ) - COLUMNAR EPITHELIUM NOT IDENTIFIED 96HR PH STUDY: DEMEESTER SCORE 23.6. TOTAL TIME OF ACID BELOW 4 IS 6.4%. SYMPTOM ASSOCIATION PROBABILITY OF 96.6 FOR REGURGITATION. THIS IS A GROSSLY ABNORMAL PH STUDY FOR ACID EXPOSURE IN THE ESOPHAGUS. ON WHAT DATE DID THE IMPLANT TAKE PLACE? (B)(6) 2020. WHEN USING THE LINX SIZING DEVICE WHAT TECHNIQUE WAS USED TO DETERMINE THE SIZE? PER ORIGINAL OP REPORT: THE POSTERIOR VAGUS NERVE WAS IDENTIFIED AND A TINY WINDOW BETWEEN THE ESOPHAGUS AND THE NERVE WAS CREATED. A PENROSE WAS ADVANCED. IT WAS THEN EXCHANGED FOR THE CALIBRATING DEVICE IN WHICH A 15 BEAD LINX DEVICE WAS FELT TO BE APPROPRIATE AFTER AT LEAST 3 DIFFERENT MEASUREMENTS. THE DEVICE WAS THEN BROUGHT IN AS A PENROSE WAS REMOVED. DID THE PATIENT HAVE AN AUTOIMMUNE DISEASE? NO AUTOIMMUNE DISEASE. IS THE PATIENT CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? PRIOR TO SURGERY NO, BUT AFTER SURGERY YES WHEN SHE WAS HAVING POSTOP DYSPHAGIA, N/V. DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? SEIZURE DISORDER, CERVICAL STENOSIS OF THE SPINE, AND ULCERATIVE COLITIS. HOW SEVERE WAS THE DYSPHAGIA/ODYNOPHAGIA BEFORE INTERVENTION? (NOT TOO SURE ABOUT THIS QUESTION, DO YOU MEAN HOW SEVERE WAS THE DYSPHAGIA BEFORE WE DID ANYTHING AT ALL? SHE WAS A GERD PT THAT PRESENTED WITH HEARTBURN, REGURGITATION, AND BELCHING, BUT NO DYSPHAGIA. OR DO YOU MEAN HOW BAD WAS HER POSTOP DYSPHAGIA BEFORE WE GAVE HER ANY MEDICATION TO HELP TREAT IT? PER HER 2 WEEK POSTOP NOTE  PATIENT STATES THAT SHE HAS BEEN VOMITING MORE OVER THE LAST 2 DAYS. THE PATIENT NOTES SHE HAS BEEN UNABLE TO EAT ANY MEALS AS SHE CANNOT KEEP ANY OF THE FOOD DOWN. HAVING DYSPHAGIA VERY SYMPTOMATIC. WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? PER OP REPORT AND TO THE BEST OF MY MEMORY NO INTRAOPERATIVE COMPLICATIONS, FAIRLY ROUTINE PROCEDURE. WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? PARAESOPHAGEAL HERNIA REPAIR WAS DONE CLOSED WITH INTERRUPTED POSTERIOR STITCHES OF 2-0 SILK". WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE REPORTED DYSPHAGIA? PER 6 WEEK FOLLOW-UP NOTE PATIENT REPORTS STRUGGLING WITH NAUSEA AND VOMITING AND NOTES THAT REFLUX SXS HAVE RETURNED AT THE BEGINNING OF (B)(6). PT STATES THAT REFLUX IS NOT AS BAD AS BEFORE BUT STATES THAT IT IS CONSISTENT AND GRADUALLY WORSENING. PT NOTES SHE IS STILL STRUGGLING WITH SWALLOWING. PATIENT REPORTS THAT SHE HAS FOLLOWED UP WITH HER PAIN MANAGEMENT AND NEUROLOGISTS WHO STATED THAT SHE NEEDED TO HAVE THE LINX DEVICE REMOVED BECAUSE THE MRI'S THAT SHE REQUIRES HAVE TO BE ABOVE 1.5 TESLA AND SHE GETS THEM FAIRLY FREQUENTLY. WHAT WAS THE REASON FOR REMOVAL OF THE LINX DEVICE? PER OFFICE NOTE: THE PATIENT WANTS TO HAVE THE DEVICE REMOVED BECAUSE SHE WAS TOLD THAT SHE WOULD NEED MRIS HIGHER THAN 1.5 WE WILL PROCEED WITH ROBOTIC CONVERSION OF LYNX TO FUNDOPLICATION. I HAVE DISCUSSED WITH THE PATIENT THAT THE DEVICE COULD STILL BE SALVAGED BUT SHE WOULD PREFER TO HAVE IT REMOVED AND CONVERT TO FUNDOPLICATION FOLLOWING HER NEUROLOGIST ADVISED OF THE MRIS. WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? YES, THE DEVICE WAS IN THE PROPER POSITION UPON REMOVAL. PER MEDICAL SAFETY OFFICER REVIEW OF ADDITIONAL INFORMATION: LES INTRA-ABDOMINAL LENGTH  0.1 CM LES RESIDUAL PRESSURE 8.8 MMHG (N-<15) ESOPHAGEAL MOTILITY  90% INTACT PERISTALSIS NO MANOMETRIC EVIDENCE OF HIATAL HERNIA. 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: WHAT IS THE PRODUCT CODE FOR THIS COMPLAINT? LOT #? DOES THE PATIENT HAVE ANY OF THE ALLERGIES TO METALS? IF SO, WHAT TEST HAVE BEEN DONE TO TEST FOR METAL ALLERGIES. WAS MESH USED AT TIME OF IMPLANT? HAVE THE SYMPTOMS RESOLVED SINCE THE DEVICE WAS EXPLANTED? WHILE THE TORAX LINX DEVICE WAS IMPLANTED, WHAT SYMPTOMS DID THE PATIENT HAVE? FROM YOUR PREVIOUS EMAIL WE HAVE: NAUSEA VOMITING EPIGASTRIC DISCOMFORT(HEARTBURN) SWALLOWING DIFFICULTY. ARE THERE ANY MORE SYMPTOMS THAT THE PATIENT HAD WHILE THE TORAX LINX DEVICE WAS IMPLANTED? ARE THERE ANY SYMPTOMS LISTED ABOVE THAT THE PATIENT DID NOT SUFFER FROM WHILE THE LINX DEVICE WAS IMPLANTED? WHAT WERE THE PATIENT'S SYMPTOMS BEFORE THE IMPLANT? WHAT WERE THE PATIENT'S SYMPTOMS DURING THE LINX WAS IMPLANTED? WHAT WERE THE PATIENT'S SYMPTOMS AFTER THE LINX WAS EXPLANTED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN LINX DEVICE WAS EXPLANTED ON (B)(6) 2021. UNKNOWN AS TO WHY THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248678 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention