MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS13; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Autoimmune Reaction (1733); Neurological Deficit/Dysfunction (1982); No Code Available (3191)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 05/28/2020.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.Additional information: autoimmune disease of pots, hypogammaglobulinemia.Test prior to implant: egd ((b)(6) 2013) - slightly irregular gej, no hiatal hernia.Normal stomach, pylorus, duodenum.48 hr bravo ((b)(6) 2013) - demeesters: 30.1 (74% time in reflux), 13.7 (31% time in reflux) esophagram ((b)(6) 2013) - no evidence of hiatal hernia.No free reflux.No pre-existing dysphagia or other conditions.No hiatal or rural repair done at the time of implant.Device was found in correct position at time of explant.No replacement device was used.Autoimmune disease: pots, hypogammaglobulinemia.No intro-operative complications during implant.No hiatal or crural repair done at the time of implant.No mesh was used at the time of implant.The device was found in the correct position/geometry at the time of removal.No replacement device was placed.The patient has chronic abdominal pain (pre-implant).As of her last postoperative visit, (b)(6) 2020, she still had persistent pain without any significant changes in her symptoms.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.Was the autoimmune and neurological conditions present before implant? what treatments is the patient receiving? did the patient¿s symptoms resolve or improve after the linx device was implanted?.

Event Description

It was reported that a linx device was explanted due to abdominal pain and concern device is exacerbating autoimmune and neurologic conditions on (b)(6) 2020.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 06/30/2020.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.The dhr for lot 4836 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Mfg date:05/jun/2013.Exp date: 05/jun/2017.

Manufacturer Narrative

(b)(4).Date sent: 06/24/2020.H10: corrected data = d4; based on additional information received.Additional information received: the product model is ls13 based on the reported lot number 4836.

• Brand Name: LS13
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10096182
• MDR Text Key: 193299803
• Report Number: 3008766073-2020-00071
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2020

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: 06/05/2017
• Device Model Number: LXMC13
• Device Catalogue Number: LS13
• Device Lot Number: 4836
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/03/2020; 06/29/2020
• Supplement Dates FDA Received: 06/24/2020; 06/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR