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

Patient Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Vomiting (2144); Insufficient Information (4580)

Event Date 08/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/25/2023.B3: unknown; captured as awareness date.No lot number was provided therefore a device history could not be done.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 through j&j medical devices per healthcare professional: ¿a patient who had received the linx device as part of the caliber study has returned to the clinic with imaging.It appears as though the device has disengaged between two beads.Up until recently, patient has done well and may in fact be interested in receiving a replacement device.

Manufacturer Narrative

(b)(4).D6a: exact implant date is unk.Assumed the first day of the month.Additional information received: spoke with julie ward who was happy to speak with us.She had only portions of the information available and will provide additional info when she can access the implant chart.The lot number for the device is 9756 but she didn¿t have the product code/size available.Patient had good results after implant in feb 2017 although did have complaints of dysphagia initially and underwent dilation one week post op which successfully resolved symptoms.Patient then began experiencing vomiting and nausea approximately six months ago which have been intermittent 1 x/week.Recent follow up imaging demonstrated a discontinuous device.Patient will be seen on 9/12 to discuss the plan but is interested in replacement since she had good success with the device.Received message from (b)(6) that patient¿s explant is scheduled for (b)(6) 2023 at (b)(6).The plan is to place another linx device at that time.A manufacturing record evaluation was performed for the finished device lot number 9756, and no related nonconformances were identified.Lot 9756 was an affected lot of the 2018 linx recall.

Manufacturer Narrative

(b)(4).The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• 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: 17623067
• MDR Text Key: 321938643
• Report Number: 3008766073-2023-00177
• 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: Other,Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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: 12/10/2019
• Device Catalogue Number: LXMC13
• Device Lot Number: 9756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention