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)

Patient Problems Dysphagia/ Odynophagia (1815); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 7/25/2023.B3: only event year known: 2023.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: if event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : no => blank.If event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : blank => n/a.Outcome : blank => recovered/resolved.Relationship to study procedure : blank => possible.End date : blank => (b)(6) 2023.Updated log line: 2 relationship to study procedure : not related => possible.Drug therapy: yes.Relationship to primary study procedure: possible.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.

Event Description

It was reported via clinical trial patient (b)(6) experience, esophageal spasms, dysphagia.Relationship to study device: not related.

Manufacturer Narrative

(b)(4).Date sent: 8/25/2023.Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number 29032, and no related nonconformances were identified.

• Brand Name: 1.5T LINX, 15B
• 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: 17388297
• MDR Text Key: 319661618
• Report Number: 3008766073-2023-00151
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC15
• Device Lot Number: 29032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR