MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 16 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM16

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing records could not be reviewed.Additional information was requested, and the following was obtained: what was the sizing technique that was used? with the seizer lss2.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no, pre existing dysphagia.How severe was the dysphagia/odynophagia before intervention? please see above.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, small hernia 3cm.Were there any other contributing factors that led to the removal of the device other than the reported odynophagia and weightloss? pain during sallow act.What was the reason for removal of the linx device? please see above.Was the device found in the correct position/geometry at the time of removal? yes.

Event Description

Patient received linx (b)(6) 2019.Now she suffered from pain when swallowing and had to be hospitalized.The patient has lost a lot of weight linx device had to be explanted (b)(6) 2019.Current status of the patient is fine.

• Brand Name: LINX 1.5T 16 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 8993156
• MDR Text Key: 158979612
• Report Number: 3008766073-2019-00430
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2019

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 Catalogue Number: LXM16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR