MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Catalog Number LXMC13

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

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883)

Event Date 01/25/2024

Event Type  Injury  

Event Description

It was reported via clinical trial patient trx_2018_01: 01290-002 experience, difficulty swallowing: no painful swallowing: no.Continuation of worsening of gerd symptoms: yes other troublesome symptom that may be related to the linx device and/or linx procedure: no.The event was not related to the study device.

Manufacturer Narrative

(b)(4).Date sent: 2/5/2024 b3: unknown; captured as awareness date lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information received: per the clinical research coordinator at site mdev-01290, the subject (002) completed their questionnaire from the pre-surgical perspective ¿ that is, there is no worsening of symptoms after linx implant.However, the progressive worsening of symptoms are what inspired them to get linx.No additional information available directly related to the questions below (there was no additional medical care outside of standard linx implant and standard post-op visit).Site reports gerd symptoms have improved after surgery." start date: 13 nov 2023 alert date: 25- jan- 2024 country of event: us model: lxmc13 device lot number: 22556 date of surgery: (b)(6) 2021 adverse event term: dysphagia patient details patient identifier: trx_2018_01: 01290-002 sex: female age (at time of consent): 64 years additional event details site awareness date: 13 nov 2023 end date: blank severity: mild is the adverse event serious? no death: no date of death: blank life-threatening illness or injury: no permanent impairment of a body structure or a body function: no required in-patient hospitalization or prolongation of existing hospitalization: no admission date: blank discharge date: blank resulted in medical or surgical intervention: no led to fetal distress, fetal death or a congenital abnormality or birth defect: no relationship to study device: causal relationship relationship to primary study procedure: causal relationship if related to the procedure, indicate which procedure the event is related to: index intervention/treatment: none: no dilation performed: no indicate type of dilation? blank date of dilation: blank diagnostic intervention: no diagnostic imaging: no drug therapy: yes observation: no linx explant: no other surgical intervention: no other intervention/treatment: no if other specify: blank outcome: not recovered/not resolved according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: n/a did this event result in the patient¿s discontinuation of the study? no model: lxmc13 device lot number: 22556 date of surgery: 04 jun 2021 adverse event term: dysphagia sex: female age (at time of consent): 64 years relationship to study device: causal relationship relationship to primary study procedure: causal relationship dilation performed: no drug therapy: yes this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(6) date sent: 2/8/2024 investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product or additional information is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device 22556 number, and no non-conformances related to the malfunction were identified.

Manufacturer Narrative

(b)(4).Date sent: 5/13/2024.Additional information received: outcome : not recovered/not resolved: recovered/resolved.Log line 1 updated outcome : recovered/resolved: not recovered/not resolved.Log line 1 updated date of dilation : blank: (b)(6) 2024.Dilation performed : no: yes.Indicate type of dilation? : blank: mechanical b1, b2, h1.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a malfunction and has been revised to a serious injury.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18640236
• MDR Text Key: 334542474
• Report Number: 3008766073-2024-00028
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2024

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 Expiration Date: 08/07/2022
• Device Catalogue Number: LXMC13
• Device Lot Number: 22556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/08/2024; 05/09/2024
• Supplement Dates FDA Received: 02/08/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female