MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 following information was requested, but unavailable: can you please follow up with the account and try to obtain the exact date of explant?.

Event Description

It was reported that the patient had a linx implanted on (b)(6) 2018.The linx implant was fine for twelve months then the patient began complaining of severe chronic epigastric pain for 5 months.The linx device was removed on an unknown date.All diagnostics for gerd showed device in proper position, functioning as expected, no gerd.Per surgeon, patient is possible opioid abuser, obese and a history of anxiety.Patient status is unknown.There was no other medical intervention.Not part of a clinical study.

Manufacturer Narrative

(b)(4).Date sent: 09/26/2019.The dhr for lot 18785 was reviewed.No defects, reworks, or ncs related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 06/24/2020.Device analysis: a partially unseated washer was observed during the visual assessment.Possible causes could be manufacturing or user related.However, the partially unseated washer did not contribute to customer¿s experience.The visual analysis excepting the unseated washer was consistent with an explanted device.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.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9087188
• MDR Text Key: 162055839
• Report Number: 3008766073-2019-00462
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2019

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: 01/16/2022
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 18785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 09/26/2019; 06/03/2020
• Supplement Dates FDA Received: 09/26/2019; 06/24/2020
• Patient Sequence Number: 1
• Patient Age: 34 YR