MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Malposition of Device (2616); Scratched Material (3020); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2016.

Event Description

It was reported that post implant of the linx, having discomfort and a small amount of pain in the hiatal area, at the end of this month or the beginning of december he will be having a conversation with his doctor on what to do next, not sure if explant or just corrective surgery will be had, the issue was diagnosed by an x-ray confirming the device magnets were all to one side, kind of vertical and it's a "c" shaped and all the little balls are at the bottom, the device has kind of "mophed" into my body.About a third of the wire is exposed.The device was implanted fall of 2016.

Manufacturer Narrative

(b)(4).Additional information received: explant did take place on (b)(6) 2019.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 04/18/2019.Device analysis: visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.The remaining device characteristics show no anomalies for a device that has been reasonably changed as part of the explant procedure.Analysis found that the returned device had an exposed weld ball visible paired with the washer side of the adjacent bead.The washer through hole was measured with computed tomography (ct) and found to be out of specification.The paired weld ball diameter was found to meet specifications.Overall review of the device function and dimensions, excluding the out of specification washer hole, show no anomalies from a device that has been reasonably changed as part of the explant procedure.As the device was tested to 250g tensile force in production, it is presumed that a certain geometric combination of the weld ball and the washer hole resulted in the device separation in vivo.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.

Manufacturer Narrative

(b)(4).Date sent: 04/23/2019.Corrected data: patient codes updated to: surgical intervention, pain.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8220501
• MDR Text Key: 132517016
• Report Number: 3008766073-2019-00234
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 04/22/2019
• Patient Sequence Number: 1