MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number LXMC14

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); No Code Available (3191)

Event Date 06/12/2019

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.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.How is the patient doing now? what was the date of implant? was a gastric emptying study done? if yes, can you please share the results? were any tests done prior to explanting the device? if yes, please share what tests were done and the results.Were there any problems noted during implant? if yes, please explain.

Event Description

It was reported that post linx implant, there was a linx removal due to moderate to severe nausea.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 09/12/2019.

Manufacturer Narrative

(b)(4).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.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.The dhr for lot 17193 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8817273
• MDR Text Key: 152025274
• Report Number: 3008766073-2019-00395
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2019

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: 11/13/2021
• Device Catalogue Number: LXMC14
• Device Lot Number: 17193
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 08/16/2019; 09/30/2019
• Supplement Dates FDA Received: 09/12/2019; 10/03/2019
• Patient Sequence Number: 1