BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 12131046 · Received July 7, 2021

    Report

    Report Number
    3008766073-2021-00137
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 29, 2021
    Report Date
    June 28, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/27/2021. 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? NO EGD. MANOMETRY YES WHICH I BELIEVE SHOWED A DISTAL HPZ. PH STUDY UNSURE. WHERE WAS THE DIVERTICULUM? ABOVE THE LINX. PRESENT BEFORE LINX PLACED. DIVERTICULUM I BELIEVE WAS MISDIAGNOSED AS A HIATAL HERNIA BY BOTH SURGEON AND AT LEAST ONE PRIOR RADIOLOGIST. ANY OBVIOUSLY MOTILITY DISORDER? AFTER LINX SOME EVIDENCE OF TERTIARY CONTRACTIONS AND DILATION. PRIOR TO THE LINX REMOVAL, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? SEE ABOVE. ON WHAT DATE DID THE IMPLANT TAKE PLACE? NOT SURE. WHAT IS THE PRODUCT CODE FOR THE LINX DEVICE THAT WAS REMOVED? UNKNOWN. YOU WOULD HAVE TO COMMUNICATE WITH THE IMPLANT SURGEON. WHAT IS THE LOT NUMBER OF THE LINX DEVICE? UNKNOWN. YOU WOULD HAVE TO COMMUNICATE WITH THE IMPLANT SURGEON. WHEN USING THE LINX SIZING DEVICE WHAT TECHNIQUE WAS USED TO DETERMINE THE SIZE? UNKNOWN. YOU WOULD HAVE TO COMMUNICATE WITH THE IMPLANT SURGEON. DID THE PATIENT HAVE AN AUTOIMMUNE DISEASE? NOT THAT I¿M AWARE OF IS THE PATIENT CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? NO. DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? YES, DYSPHAGIA, PROBABLY FROM FOOD CATCHING IN THE DIVERTICULUM. HOW SEVERE WAS THE DIVERTICULUM BEFORE INTERVENTION? LARGE, APPROX. 4 CM CIRCUMFERENCE WITH 2 CM INTROITUS WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? UNKNOWN. YOU WOULD HAVE TO COMMUNICATE WITH THE IMPLANT SURGEON. WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? I BELIEVE THAT A CRURAL REPAIR WAS DONE. WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE REPORTED DIVERTICULUM? THE CAUSE OF AN ESOPHAGEAL DIVERTICULUM IS USUALLY THE PRESENCE OF A DISTAL HPZ, WHICH I BELIEVE WAS PRESENT WHEN ONE LOOKS CAREFULLY AT THE PREOPERATIVE MANOMETRY STUDY. PLACEMENT OF A LINX ON TOP OF THAT WOULD ONLY EXACERBATE THE SITUATION. BESIDES THE REPORTED DIVERTICULUM, WHAT WAS THE REASON FOR REMOVAL OF THE LINX DEVICE? THE NEED FOR A DISTAL MYOTOMY. WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? YES. 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: DUE TO THE QUESTIONS WE SENT AND THE RESPONSE WE RECEIVED, WE HAVE ADDITIONAL QUESTIONS. PLEASE READ THE FIRST 2 QUESTIONS CAREFULLY. WE ARE ASKING ¿PRIOR TO LINX PLACEMENT¿ AND THEN ¿PRIOR TO THE REMOVAL OF THE LINX PLACEMENT¿ PRIOR TO LINX PLACEMENT, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? PRIOR TO THE LINX REMOVAL, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? ON THE BELOW QUESTIONS YOU STATED ¿UNKNOWN. YOU WOULD HAVE TO COMMUNICATE WITH THE IMPLANT SURGEON.¿ DO YOU HAVE THE IMPLANT SURGEON NAME AND CONTACT INFORMATION? WHAT IS THE PRODUCT CODE FOR THE LINX DEVICE THAT WAS REMOVED? WHAT IS THE LOT NUMBER OF THE LINX DEVICE? WHEN USING THE LINX SIZING DEVICE WHAT TECHNIQUE WAS USED TO DETERMINE THE SIZE? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT?

    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. 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: PRIOR TO LINX PLACEMENT, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? WHERE WAS THE DIVERTICULUM? ANY OBVIOUSLY MOTILITY DISORDER? PRIOR TO THE LINX REMOVAL, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? ON WHAT DATE DID THE IMPLANT TAKE PLACE? WHAT IS THE PRODUCT CODE FOR THE LINX DEVICE THAT WAS REMOVED? WHAT IS THE LOT NUMBER OF THE LINX DEVICE? WHEN USING THE LINX SIZING DEVICE WHAT TECHNIQUE WAS USED TO DETERMINE THE SIZE? DID THE PATIENT HAVE AN AUTOIMMUNE DISEASE? IS THE PATIENT CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? HOW SEVERE WAS THE DIVERTICULUM BEFORE INTERVENTION? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE REPORTED DIVERTICULUM? BESIDES THE REPORTED DIVERTICULUM, WHAT WAS THE REASON FOR REMOVAL OF THE LINX DEVICE? WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED (B)(6) 2021 DUE TO THE PATIENT DEVELOPING A DIVERTICULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026941 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention