MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC14; ANTI-REFLUX IMPLANT

Model Number	LXC-[14]
Health Effect - Clinical Codes	Heartburn/Indigestion (1883); Hernia (2240); No Code Available (3191)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 3/19/2020.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.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.Were you present during the explant procedure? what is the lot number for the linx device? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? was a hiatal hernia repair done during the implant procedure?.
Event or Problem Description
It was reported that the linx device was explanted on (b)(6) 2020 due to recurring gerd and a hiatal hernia.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 04/13/2020.Additional information was requested, and the following was obtained: were you present during the explant procedure? - answer: no.What is the lot number for the linx device? - answer: unknown.Was ph testing performed prior to explant to confirm recurrent reflux? - answer: no.After implant, was the device initially effective in controlling reflux? - answer: yes.When did the recurrent reflux begin? - answer: (b)(6) 2019.Was a hiatal hernia repair done during the implant procedure? - answer: unknown.
Additional Manufacturer Narrative
(b)(4).Date sent: 05/04/2020.Device analysis: 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 visual analysis was consistent with an explanted device.The link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The device lot number is unknown; therefore, the device history record could not be reviewed.

• Brand Name: LXC14
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9856053
• Report Number: 3008766073-2020-00049
• Device Sequence Number: 2663640
• Product Code: LEI
• UDI-Device Identifier: 00855106005158
• UDI-Public: 00855106005158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2020

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 Model Number: LXC-[14]
• Device Catalogue Number: LXC14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/23/2020; 04/23/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/13/2020; 05/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention