MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested and the following was received: lot #?-information not provided.Does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunization drugs?-information not provided.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)?-information not provided.Was there any hiatal or crural repair done at the same time as the implant?-information not provided.Was mesh used at time of implant?-information not provided.At the time of removal, was the device found in the correct position/geometry at the time of removal?-information not provided.Have the symptoms resolved since the device was explanted?-information not provided.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the linx device was explanted on (b)(6).Implanted (b)(6) 2019 at unknown facility.Device was removed due to patient complaints that device significantly decreased her quality of life.

Manufacturer Narrative

(b)(4).Date sent: 08/26/2020.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 lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10356578
• MDR Text Key: 201544391
• Report Number: 3008766073-2020-00111
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention