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

Catalog Number LXM15

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Pc (b)(4).Assumed 1st day of the month for implant date.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The dhr for lot 26471 was reviewed.No ncs, defects, or reworks related to the product complaint were found additional information was requested, and the following was obtained: was the patient admitted to the hospital on (b)(6) 2021? yes.If yes, how many days was the patient admitted to the hospital? 4.What was the exact implant date? (b)(6) 2021.Was ph testing performed prior to explant to confirm recurrent reflux? yes, also manometry, x-ray swallow.After implant, was the device initially effective in controlling reflux? yes.When did the recurrent reflux begin? 2-3 weeks before explant said the patient, but the diagnostic shows normal results it seems that the patient has a psychologic problems.So what kind of information or pictures you need? 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: in the additional information received we asked: what was the exact implant date? the answer was (b)(6) 2021.That was the explant date.We are looking for the exact implant date.What was the exact implant date? it was also stated in the ai ¿so what kind of information or pictures you need¿? please let us know the exact implant date (if known).If there is any other information or photos that you have and you would like to share, please do so.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a linx device, lxm15, lot 26471 implanted on (b)(6) in 2020.During implantation the patient has received hiatoplasty.(b)(6) 2021 renewed presentation in the hospital.The patient again suffered from severe reflux and pain.An inspection did not reveal any findings.At the patient's own request, the implant was removed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).Date sent: 6/23/2021.Additional information was requested, and the following was obtained: in the additional information received we asked: what was the exact implant date? the answer was (b)(6) 2021.The was the explant date.We are looking for the exact implant date.What was the exact implant date? (b)(6) 2018.It was also stated in the ai ¿so what kind of informations or pictures you need¿ please let us know the exact implant date (if known).If there is any other information or photos that you have and you would like to share, please do so.Answer= so please let sales rep know which kind of material you need x.Ray, endoscopic pictures etc.

• Brand Name: LINX 1.5T 15 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 12035491
• MDR Text Key: 259646720
• Report Number: 3008766073-2021-00119
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2023
• Device Catalogue Number: LXM15
• Device Lot Number: 26471
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR