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

Catalog Number LXMC14

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent 4/5/2024 d4 batch # unk b3: unknown; captured as awareness date d6a: exact date unk.Implanted in 2018.Assumed first day of the month and the first month of the year.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.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 that patient had a size 14 linx implanted for treatment of gerd in 2018 at an unknown facility in north carolina.Patient began recently treating with another physician for return of symptoms and device was found to be discontinuous.Patient is in the process of scheduling removal of the linx device and counsel for patient will allow device analysis and provide necessary information.

Manufacturer Narrative

(b)(4).Date sent: 5/1/2024.A manufacturing record evaluation was performed for the finished device 17614 number, and no non-conformances related to the malfunction were identified.

Manufacturer Narrative

(b)(6) date sent: (b)(6)2024 additional information received: spoke with patient who indicated her explant procedure is scheduled for 5/21.She is agreeable to releasing device for analysis and is no longer represented by counsel.Spoke with daniel in surgeon¿s office who was in clinic and will respond when free.

Manufacturer Narrative

(b)(4).Date sent: 6/11/2024.Investigation summary.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, the device was received with one bead disconnected and during the analysis, it was noted that wires were cut.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.A manufacturing record evaluation was performed for the finished device 17614 number, and no non-conformances related to the malfunction were identified.

• Brand Name: 1.5T LINX, 14B
• 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: 19049458
• MDR Text Key: 339462825
• Report Number: 3008766073-2024-00054
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2024

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 Operator: Health Professional
• Device Expiration Date: 11/29/2021
• Device Catalogue Number: LXMC14
• Device Lot Number: 17614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/26/2024; 05/03/2024
• Supplement Dates FDA Received: 05/01/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• 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 Sex: Female