MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dhr for lot 21484 was reviewed.No defects, reworks, or ncs related to the product complaint were found.Additional information was requested, and the following was received: the patient was highly dissatisfied with the outcome of the procedure.Pt couldn¿t eat at all, had lots of continuous pain, even without food.Diagnostics that were done was he scoped and did a barium swallow, only a little more than half of it got past.Decision to remove the device was solely based on the patient¿s comfort level and what she wanted.What is the implant date? implant date was (b)(6) 2020 and explant date was (b)(6) 2020.What is the product code for this complaint? product code: lxmc17.What is the lot number for this complaint? lot number: 21484.What type of ¿examination¿ revealed half of the food passed through the device? barium swallow, only a little more than half of it got past les/linx.What is the current condition of the patient? patient had device removed and no complaints after removal.Did the patient suffer from dysphagia (difficulty swallowing)? not described, just painful while eating and even when not eating.If yes for dysphagia, how severe was the dysphagia/odynophagia before intervention? n/a was the device found in the correct position/geometry at the time of removal? yes the device size and location were exactly what should be.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Besides pain, were there any other contributing factors that led to the removal of the device other than the reported dysphagia? no.Where there any motility studies before and after the placement of the linx and if yes can you please share the results? scope was done and everything looked great, nothing of concern.Correct placement on device and properly sized linx.Any autoimmune disease? no.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that post implant of a linx device the patient complained of pain and could not eat.Examination revealed half of food passed through the device and half did not.The device was ex-planted on (b)(6) 2020.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 10382077
• MDR Text Key: 202187263
• Report Number: 3008766073-2020-00117
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 21484
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention