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Patient 1
(B)(4). DATE SENT: 3/19/2020. DATE OF EVENT: ONLY EVENT YEAR KNOWN: 2020. 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 IS THE LOT NUMBER FOR THE LINX DEVICE? WAS PH TESTING PERFORMED PRIOR TO EXPLANT TO CONFIRM RECURRENT REFLUX? AFTER IMPLANT, WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? WHEN DID THE RECURRENT REFLUX BEGIN? WHAT SYMPTOMS LEAD TO THE DISCOVERY OF THE DISCONTINUOUS DEVICE? WHEN DID THEY BEGIN? WHAT WAS THE DATE OF THE IMAGING WHICH SHOWED THE DISCONTINUOUS LINX? IF AVAILABLE, PLEASE SHARE A COPY OF THIS IMAGING. WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? IF SO, WHEN WAS THE MRI AND WHAT STRENGTH? DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? WAS ANY ADDITIONAL IMAGING PERFORMED SINCE DEVICE IMPLANT? DOES THE DEVICE APPEAR TO BE IN A CONTINUOUS ANNULAR STATE IN THESE IMAGES? WE ARE INTERESTED IN ESTABLISHING A WINDOW WHEN THE DEVICE MAY HAVE BECOME DISCONTINUOUS. PLEASE SHARE ANY ADDITIONAL IMAGES.