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

Catalog Number LXMC14

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/14/2020.Event date: only even year is known: 2020.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.Additional information: device removed was a size 14.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Request for additional information will be sent.If additional information is received a supplemental medwatch will be sent.

Event Description

It was reported that a linx device will be explanted at an unknown date.No other information is available.

Manufacturer Narrative

(b)(4).Date sent: 1/26/2021.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The dhr for lot: 25583 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: on what date did the implant take place? on (b)(6) 2020.Lot#? 25583.Does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies? denied allergy before surgery, but after surgery remembered that she does sometimes have reactions to certain jewelry.Is the patient currently taking currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no.What was the reason for removal of the linx device? refractory spasms.At the time of removal, was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted? yes.What is the product code for this complaint? lxm13.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: date of explant (b)(6) 2020.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: on what date did the implant take place? on what date did the explant take place? what is the product code for this complaint? lot #? 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? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? what was the reason for removal of the linx device? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? will the device be sent back for analysis?.

Manufacturer Narrative

(b)(4).Date sent: 3/2/2021.H6: no device problem found (c19).Please see h11.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.Additional information received: the correct product code should be lxmc14.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11004343
• MDR Text Key: 221484095
• Report Number: 3008766073-2020-00202
• 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: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2023
• Device Catalogue Number: LXMC14
• Device Lot Number: 25583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 02/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention