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

Catalog Number LXMC14

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2018.Batch # unk.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.As a lot/batch was not provided, a device history could not be performed.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: what was the device size implanted (number of beads)? was this the clasp linx or the suture linx? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? did the dysphagia improve after the device was implanted initially? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal?.

Event Description

It was reported post implant of linx, tcfl.Patient had gi complaints that were likely due to ibs/constipation; however, she would not follow instructions and continued to complain of pain with eating and dysphasia.She kept coming back stating she wanted it out and i got tired of fighting her on it.Cxr showed hadn¿t migrated, egd showed no erosion, barium swallow showed mild to moderate dysmotility but easy passage of contrast into the stomach.Linx removal was on (b)(6) 2018.

Manufacturer Narrative

(b)(4).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 device lot number is unknown; therefore the device history record could not be reviewed.Lot number unknown.No dhr review performed.

Manufacturer Narrative

(b)(4).Date sent: 12/06/2018.Additional information was requested and the following was obtained: what was the device size implanted (number of beads)? 14.Was this the clasp linx or the suture linx? clasp.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? yes.Had large fixed hiatal hernia.Also had schatzki¿s ring in past that had been dilated.How severe was the dysphagia/odynophagia before intervention? mild to moderate.Did the dysphagia improve after the device was implanted initially? 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.What was the reason for removal of the linx device? persistent complaints of dysphagia.Was the device found in the correct position/geometry at the time of removal? yes.Furthermore, egd, cxr, and ems all normal prior to removal.Patient unwilling to try dilation.Implant placed (b)(6) 2016.Explanted (b)(6) 2018.

• 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: 8101262
• MDR Text Key: 128254768
• Report Number: 3008766073-2018-00207
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 11/28/2018; 12/03/2018
• Supplement Dates FDA Received: 12/06/2018; 12/14/2018
• Patient Sequence Number: 1