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

Model Number LXMC13

Device Problems Device Appears to Trigger Rejection (1524); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Speech Disorder (4415)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2021.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 was requested, and the following was obtained: what is the product code? lxmc13.What is the device lot number? 14056.Scheduled for explant on (b)(6) 2021.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: when did the symptoms begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.What is the product code? what is the device lot number? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? when is the explant date scheduled for? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? 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 the linx device was implanted (b)(6) 2017 for gerd.The patient has recently been experiencing hoarseness, shortness of breath and dysphagia.It was discovered that one of the wires has separated from the beads.The device will be explanted but a date has not been set.No other information is available at this time.

Manufacturer Narrative

(b)(4).Date sent: 10/26/2021.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.The dhr for lot 14056 was reviewed.No ncs, defects, or reworks related to the product complaint were found.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: was the device explanted on (b)(6) 2021? when did the patient symptoms begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.Is a replacement linx or fundoplication planned? will the device be returned for analysis? if yes, to whom should the shipper kit be sent to? please include full name and address?.

Manufacturer Narrative

(b)(4).Date sent: (b)(6)2021.Additional information received: it was reported by the patient that her device was implanted about four years ago and this year when she went for her yearly checkup that her barium swallow showed that her device had broken.Her device was explanted about a month ago.Attempted to reach patient who was unavailable.Left message in her voicemail with contact information and reason for call.

Manufacturer Narrative

(b)(4).Date sent: 2/15/2022.Additional information received: spoke with rep who indicated the device wasn't preserved at the hospital and is not available for analysis.He is requesting pre explant imaging and will get back to us once available.

Manufacturer Narrative

(b)(4); date sent: 10/6/2022.D6b: exact explant date is unknown.On (b)(6) 2021 the explant "took place about a month ago".The exact explant date is unknown.Estimated explant date will be (b)(6) 2021.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 12520409
• MDR Text Key: 272970555
• Report Number: 3008766073-2021-00196
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/06/2022

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: 02/27/2021
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 14056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 10/26/2021; 11/30/2021; 01/25/2022; 10/06/2022
• Supplement Dates FDA Received: 10/26/2021; 12/14/2021; 02/15/2022; 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention