MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

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

Patient Problems Bacterial Infection (1735); Dysphagia/ Odynophagia (1815); Vomiting (2144)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported via clinical trial patient experience vomiting.

Manufacturer Narrative

(b)(4).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: panhandle surgical group.Sex: female.Age (at time of consent): (b)(6).Model: lxmc15.Device lot number: 28530.Date of surgery: (b)(6) 2021.Adverse event term: vomiting.Severity: severe.Is the adverse event serious? yes.Required in-patient hospitalization or prolongation of existing hospitalization: yes.Admission date: (b)(6) 2021.Discharge date from hospital: (b)(6) 2021.Intervention/treatment: diagnostic intervention: yes.Diagnostic imaging: yes.Drug therapy: yes.

Manufacturer Narrative

(b)(4).Date sent: 1/11/2021.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.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.Additional information received: 28530 is not a valid lot number.

Manufacturer Narrative

(b)(4).Date sent: 3/8/2022.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.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.No further investigation will be conducted on this complaint as the device is found to meet the specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed for the finished device batch number: 25221, and no non-conformances were identified.Additional information received: patient developed of a left sided empyema requiring thoracotomy with decortication.Required in-patient hospitalization or prolongation of existing hospitalization: yes.Admission date: on (b)(6) 2022.Discharge date: on (b)(6) 2022.Relationship to study device: causal relationship.Relationship to primary study procedure: causal relationship.Dilation performed: yes.Indicate type of dilation? pneumatic.Date of dilation: on (b)(6) 2021.Diagnostic intervention: yes.Diagnostic imaging: yes.Drug therapy: yes.Linx explant: yes.According to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: yes.

Manufacturer Narrative

(b)(4).Date sent: 2/24/2022.Additional information received: device lot number: 25221.Dysphagia / moderate.Pneumatic dilation was performed on (b)(6) 2021.Relationship to study device: casual relationship.Relationship to study procedure: casual relationship.Diagnostic imaging was done.Drug therapy was provided.(prescription based).Outcome: recovering/resolving.Did this event result in the subject's discontinuation of the study? yes.Linx explant was done.Was the linx explant a result of an adverse event per protocol definitions?: yes.If yes, choose the primary ae log line, start date and term: #002 on (b)(6) 2021-dysphagia participant had anxiety about implant: no.Medical need for high field strength mri or other testing: no.Participant wishes to have alternative gerd treatment requiring linx explant: no.Continued gerd symptom: no.Laparoscopic: yes.The date of the explant was on (b)(6) 2022.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.

Manufacturer Narrative

(b)(4); date sent: 10/28/2022.Additional information received: end date : blank - (b)(6) 2022.Outcome : recovering/resolving: recovered/resolved.

Manufacturer Narrative

(b)(4).Date sent: 8/21/2023.Additional information received: awareness date : 01 dec 2021 - 16 nov 2021.Awareness date : 16 nov 2021 - 01 dec 2021.Based on the audit trail for this implant.The lot# was corrected to 28536 on 18jan2023.

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 12952407
• MDR Text Key: 282780669
• Report Number: 3008766073-2021-00239
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 08/21/2023

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 Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 28536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/11/2022; 02/09/2022; 02/25/2022; 10/27/2022; 08/10/2023
• Supplement Dates FDA Received: 01/11/2022; 02/24/2022; 03/08/2022; 10/28/2022; 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 82 KG