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

Catalog Number LXMC16

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); No Code Available (3191)

Event Date 02/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: what was the reason for removal of the linx device? chest pain.If dysphagia, how severe was the dysphagia/odynophagia before intervention (mild, moderate or severe)? no dysphagia.Did the patient have an autoimmune disease? no autoimmune disease.Is the patient currently taking steroids / immunization drugs? no steroids.When was the linx device implanted? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? peh done at implant.Was the device found in the correct position/geometry at the time of removal? was a new linx placed after this one was removed? no re-implant ¿ partial fundo.

Event Description

It was reported that the linx was explanted.Reason for removal of the linx device, chest pain.

Manufacturer Narrative

(b)(4).Date sent: 04/18/2019.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 device lot number is unknown; therefore, the device history record could not be reviewed.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8439617
• MDR Text Key: 139433292
• Report Number: 3008766073-2019-00297
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 04/18/2019
• Patient Sequence Number: 1