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

Catalog Number LXMC17

Device Problem Break (1069)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Obstruction/Occlusion (2422); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year is known: 2019.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 was requested, and the following has been received: do you have the serial number (if applicable)? no, but the lot# was 10717 on what date was the device implanted? (b)(6) 2017.The event description stated that the device will be removed on (b)(6) 2019.Was the device explanted on (b)(6) 2019? yes.If no, when is the next expected date for the device to be removed? was there a replacement done at the same time of explant? no.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Please specify the symptoms the patient was experiencing prior to implant (gerd reflux, dysphagia, pain during eating, at night, etc., )? gerd, heartburn, regurgitation, epigastric pain, sore throat and hoarseness.Please specify the symptoms the patient was experiencing while the device was implanted (gerd reflux, dysphagia, pain during eating, at night, etc., )? gerd, chest pain, difficulty eating, esophageal obstruction.Had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? yes.If yes, what diagnostic testing was done and have they received the test results? yes, egd and upper gi.Do we have permission to contact the physician that performed the explant? yes.If yes, what is the surgeon's name, address and telephone number.(b)(6).Did they have an autoimmune disease? no.Has the patient been prescribed medication? no.If yes, why was the medication prescribed? was the medication prescribed to treat the dysphagia, gerd, etc.Were they taking this medication prior to implant ? are they currently taking steroids / immunization drugs? no.

Event Description

It was reported, ¿a discontinuous linx device lxmc17 was discovered and will be removed and replaced.Tentative date is (b)(6) 2019.

Manufacturer Narrative

(b)(4).Date sent: 08/12/2019.

Manufacturer Narrative

(b)(4).Date sent: 07/10/2019.The dhr of lot 10717 was reviewed.No ncs, defects, or reworks related to the pc were found.Lot 10717 is an affected lot of the 2018 linx recall.

Manufacturer Narrative

(b)(4).Date sent: 08/14/2019.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 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.

• 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: 8744720
• MDR Text Key: 149519788
• Report Number: 3008766073-2019-00381
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: LXMC17
• Device Lot Number: 10717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Date Manufacturer Received: 08/13/2019
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1