MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Model Number LXMC14

Device Problems Device Appears to Trigger Rejection (1524); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Vomiting (2144); Weight Changes (2607); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/31/2017

Event Type  Injury  

Event Description

See medwatch mw 3008766073-2017-00029.

Manufacturer Narrative

(b)(4).Investigation summary: device analysis conducted by torax medical engineering after product receipt.Gross analysis revealed no device anomalies atypical from an explanted device.Microscopic analysis revealed all device components and assembly exhibited normal characteristics of an explanted device.Force testing, length testing, and geometric analysis exhibited no anomalies.No conclusion relevant to experience determined.The medical safety officer reviewed the files for this legacy complaint and device analysis.Per the mso's review, there was nothing to add.A manufacturing record evaluation was performed for the finished device batch number 9472, and no non-conformances were identified.Additional information provided: a linx device was explanted due to a subsequent mri for his shoulder.Prior to the linx implant, the patient had some pre-existing dysphagia and had undergone barrett¿s ablation.A hernia was repaired during the implant surgery.After implant, the patient had some dysphagia with esophageal regurgitation that was treated with medication and resolved.On (b)(6) 2016, an egd was done showing a normal ge junction; a biopsy was taken from the ge junction and barrett¿s mucosa was found without dysplasia.On (b)(6) 2016, a barium swallow was done revealing a pill sticking at the ge junction/linx device.The patient had a history of a prostatectomy in 2010 and a recurrence of prostate cancer after august 2016.The patient developed some shoulder discomfort and was told that he needed to have an mri to accurately diagnosis his shoulder injury.The patient was placed in proximity of an mri and had significant esophageal and chest pains and had to cease the mri.At that point, the patient requested the removal of the device rather than an endoscopy with dilation as suggested by the surgeon.Update 13-feb-17: the patient tried to have an mri on his shoulder on (b)(6) 2016 and could not tolerate it.The patient said it was ¿of a lesser strength than 1.5t¿.Update 16-feb-17: a phone call with susan at ga sports medicine led to the discovery that the attempted mri on (b)(6) was done at tift regional medical center.A phone call with lori at tift regional (mri department) said that the mri was done at ga sports medicine, however a ct scan was done on the patient¿s shoulder on (b)(6) 2016.Another message has been left with ga sports medicine to close the loop and determine what level mri was attempted and if any notes were made.Device and traceability review found no anomalies or non-conformities.The patient decided to have the device removed in order to have an mri.There was no further response with ga sports medicine or the hospital about the first attempted mri which the patient could not tolerate despite multiple requests for the information as described above.The labeling and risk management documents cover the risks associated with mris and device reoperation/removal.Fer monitoring will track and trend.Based on this information, the case may be closed.Dysphagia after operation with esophageal regurgitation treated with medication and resolved.No intra op complications during implant.There was a hernia repair done at the time of implant.No mesh was used at the time of implant.The device was found in the correct position at the time of explant.No replacement device.Weight loss of 20lbs the first 2 weeks after surgery.Patient deferred dilation.Spasms.No fundoplication.Implant card information: "patient should not be exposed to an mri environment greater than 1.5 tesla".The mri the patient tried to have on shoulder and could not tolerate was on (b)(6) 2016 and of a lesser strength than 1.5t.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4), date sent: 8/23/2022.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126 ; 329348013
• MDR Report Key: 15274757
• MDR Text Key: 298396040
• Report Number: 3008766073-2022-00167
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2019
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 9472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG