MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS14; ANTI-REFLUX IMPLANT

Catalog Number LS14

Device Problem Defective Component (2292)

Patient Problems Pyrosis/Heartburn (1883); No Code Available (3191)

Event Date 05/22/2015

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.Additional information: pre implant barium swallow, ph, egd.No pre existing dysphagia or other conditions other than gerd.No intra op complications during implant.No hiatal or crural repair done at time of implant.No mesh used at the time of implant.Device was found in correct position.Lix replacement 14 bead, lot: (b)(4).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.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? did the patient undergo an mri since device implant? if so, when was the mri and what strength? the lot number reported, (b)(4) corresponds to an ls14 device and not the reported lxmc14.Please confirm the product code and lot number for the linx device that was removed.

Event Description

It was reported that post implant that subject with linx device 14 bead clasp, lot # 5006, serial # (b)(4) suffered from ongoing gerd.The device was implanted on (b)(6) 2015 and explanted: (b)(6) 2019.The device was removed with several bead/magnets demagnetized.A similar device was implanted.

Manufacturer Narrative

Pc-(b)(4).Date sent: 07/22/2019.The dhr for lot 5006 was reviewed.No ncs, reworks, or defects related to the pc were found.Additional information was requested, and the following was obtained: was ph testing performed prior to explant to confirm recurrent reflux? a bravo study was completed in (b)(6) 2017.The surgeon made a comment on her progress note indicating that the ph study was conducted revealed pathologic amounts of reflux.After implant, was the device initially effective in controlling reflux? her reflux became an issue in 2017.It was recommended for patient to undergo egd/bravo and video esophagram and to follow up with an office visit.When did the recurrent reflux begin? early 2017.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? there is no documentation of a mri that shows up on our hoag records.Patient did not report to us that she had undergone a mri.The model number is ls14, lot number is 5006, and serial number is (b)(6).

Manufacturer Narrative

(b)(4).Date sent: 11/19/2019.Device analysis: the device was returned in two pieces ¿ a 5-bead and a 9-bead segments.The notable findings were: 1) the visual analysis revealed that the 9-bead segment had three demagnetized/depolarized beads.This was confirmed during tensile testing.2) the tensile testing of the 5-bead segment suggest that a few beads may have higher than specified separation force.The separation force was just within the specification in two graphs and outside the specification in the other two graphs.This can be explained by the bent links which in some orientations were ¿catching¿ inside the beads.In addition, the production data was reviewed using the serial number (b)(6) provided by the customer.Based on the serial number, the device average link length and bead separation forces were within specification during production inspection.Therefore, the device investigation suggests that the device was likely damaged during use.The nature of the failure (reduced magnet strength, depolarization, and bent links) suggests exposure to a static magnetic field.The device is mr unsafe.

Manufacturer Narrative

(b)(4).Date sent: 01/02/2020.Additional information requested and received: did the patient have an mri outside of the hoag system? response: voicemail left for the patient on (b)(6) 2019 and (b)(6) 2019 and the account has not heard back from the patient.The patient was scheduled for an appointment but no showed to that appointment.

Manufacturer Narrative

(b)(4).Date sent: 01/14/2020.Additional information received: the office called offering to reschedule her appointment.She declined to reschedule.

Manufacturer Narrative

(b)(4).Date sent: 01/14/2020.H10: corrected supp = updated h6 (epigastric discomfort).

• Brand Name: LS14
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8711967
• MDR Text Key: 148422033
• Report Number: 3008766073-2019-00375
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/04/2019

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: 07/22/2017
• Device Catalogue Number: LS14
• Device Lot Number: 5006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 06/25/2019; 10/29/2019; 12/10/2019; 01/14/2020; 01/14/2020
• Supplement Dates FDA Received: 07/22/2019; 11/19/2019; 01/02/2020; 01/14/2020; 01/14/2020
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 79