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Patient 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. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. 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 WAS THE REASON FOR REMOVAL OF THE LINX DEVICE? PRIOR TO LINX PLACEMENT, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? THE PRODUCT CODE REPORTED WAS THE LXMC14. CAN YOU PLEASE PROVIDE THE LOT NUMBER? WHEN USING THE LINX SIZING DEVICE WHAT TECHNIQUE WAS USED TO DETERMINE THE SIZE? DOES THE PATIENT HAVE ANY OF THE ALLERGIES TO METALS? IF SO, WHAT TEST HAVE BEEN DONE TO TEST FOR METAL ALLERGIES. IS THE PATIENT CURRENTLY TAKING CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? WAS MESH USED AT TIME OF IMPLANT? AT THE TIME OF REMOVAL, WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? HAVE THE SYMPTOMS RESOLVED SINCE THE DEVICE WAS EXPLANTED?