MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994); Choking (2464); Insufficient Information (4580)

Event Date 06/03/2021

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.No lot number was provided therefore a device history could not be done.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? what is the product code? 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?.

Event Description

It was reported that a linx device was explanted (b)(6) 2021.Unknown as to the reason for explant at this time.

Manufacturer Narrative

(b)(4).Date sent: 6/23/2021.Additional information was requested, and the following was obtained: on what date did the implant take place? (b)(6) 2018.Product code? lxmc15.Lot number? lot 18366.Does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Unknown.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)? according to h&p (b)(6) 2018: has dysphagia to solid food dysphagia and occasionally liquids; did have manometry that showed 100% peristalsis.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? recurrence of daily heartburn, epigastric pain, hiccups, aspiration with choking events at night at least 3x a week, hx prior sleeve gastrectomy.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.The dhr for lot 18366 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Corrected data = (b)(4).D4 = lxmc15.

Manufacturer Narrative

(b)(4).Date sent: 7/26/2021.H6: no device problem found (c19).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.No further investigation will be conducted on this complaint as the device is found to meet the specifications.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 12033727
• MDR Text Key: 257399810
• Report Number: 3008766073-2021-00118
• 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
• Report Date: 06/03/2021

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 Expiration Date: 12/21/2021
• Device Catalogue Number: LXMC15
• Device Lot Number: 18366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 06/21/2021; 07/08/2021
• Supplement Dates FDA Received: 06/23/2021; 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention