MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 13 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM13

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); No Code Available (3191)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 06/10/2020.The dhr for lot 24182 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was received: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? yes, the diagnostic was ideal for linx,- gi don¿t want to share the details.When using the linx sizing device what technique was used to determine the size? with the sizer, consider sizing by md lipham.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.How severe was the dysphagia/odynophagia before intervention? high.Were there any intra-operative complications during implant? no.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? no.What was the reason for removal of the linx device? weight lost, pain, strong dysphagia.Was the device found in the correct position/geometry at the time of removal? yes.

Event Description

It was reported: implant date: (b)(6) 2020.Diagnosis: gerd, small hiatal hernia, op: hiatoplasty 1 x before hiatoplasty, 2 x rear hiatoplasty.No complications.Discharge (b)(6) 2020, complaint-free.Re-presentation of the patient on (b)(6) 2020 wg.Dysphagia treatment with cortisone new presentation of the patient on (b)(6) 2020.Severe dysphagic complaints.(b)(6) explantation.(b)(6) 2020 patient is fine, symptom-free, no complaints, no reflux.

• Brand Name: LINX 1.5T 13 BEAD OUS
• 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: 10140502
• MDR Text Key: 194780754
• Report Number: 3008766073-2020-00075
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Catalogue Number: LXM13
• Device Lot Number: 24182
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR