MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC16; ANTI-REFLUX IMPLANT

Model Number	LXC-[16]
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Heartburn/Indigestion (1883)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 2/1/2021.Initial details of this event were previously reported 03/15/2017.Received notification from fda that the report did not reach ack3/passed status.However, the follow-up report was received.Resending initial report with all details contained.
Event or Problem Description
It was reported that following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd and moderate dysphagia leading to linx device explant.The linx device was used as part of the anti-reflux procedure.Uneventful anti-reflux procedure including hernia repair and device implant on (b)(6) 2013.Uneventful device explant on (b)(6) 2017; linx device noted as densely encapsulated at time of removal.Device found in correct position/geometry at time of explant.Immediately after device explant the patient had a replacement linx device implanted (model: lxmc17).

• Brand Name: LXC16
• Common Device Name: 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, MN 55126 ; 6107428552
• MDR Report Key: 6518735
• Report Number: 3008766073-2017-00033
• Device Sequence Number: 3786676
• Product Code: LEI
• UDI-Device Identifier: 00855106005172
• UDI-Public: 00855106005172
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2017
• Device Model Number: LXC-[16]
• Device Catalogue Number: LXC16
• Device Lot Number: 4865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 04/25/2017
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 89 KG