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

Catalog Number LXMC14

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 08/12/2019

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.Additional information was requested, and the following was obtained: what is the product code for the linx device? what symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send the image to productcomplaint1@its.Jnj.Com.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.Response: patient gender: female, patient initials: (b)(6), date of birth: (b)(6), patient bmi or weight: 23.3.Date of implant: (b)(6) 2017, date of explant: (b)(6) 2019, implanting physician: dr.(b)(6), device size: 14-bead (clasp), lot: 12203.Did the patient have any of the following (autoimmune disease, allergy to metals, other metal implants ¿ orthopedic, cardiac, etc)? this question was not answered.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.Were there any intra-operative complications during implant? no.Was there a hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no.What was the reason for removal of the linx device? ongoing gerd symptoms.Was the device found in the correct position / geometry at the time of removal? no.Linx device was found to be in discontinuity intra-operatively.Was a replacement linx device used? no.A video of the explant was taken.The linx device was retained.Pre-implant information: which tests were performed per-implant? manometry, barium swallow, ph, egd.Results: video esophagram- small to moderate hiatal hernia, esophageal dysmotility.Em- ineffective esophageal motility, low les pressure, hiatal hernia.Dci 432.3.Egd- 3 cm hiatal hernia, hill grade 4 valve, no esophagitis.48 hr ph study, demeester scores: 52.4, 34.5.Additional diagnostic testing or intervention performed prior to removal: veg ((b)(6) 2018) - esophageal dysmotility, no gastroesophageal reflux, no hiatal hernia.Linx intact.Egd ((b)(6) 2018) - la grade b esophagitis, 2 cm hiatal hernia.Ct chest ((b)(6) 2019) - linx is disconnected on imaging (radiologist did not report).Ct abdomen/pelvis ((b)(6) 2019) - linx device for management of gastroesophageal reflux at ge junction has separated with a gap measuring approximately 1.3 cm.Surgical consultation is indicated.

Event Description

It was reported that post implant of a linx device, the device is now found to be disconnected and will be explanted on (b)(6) 2019.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 10/09/2019.The dhr for lot 12203 was reviewed.No ncs, reworks, or defects related to the product complaint were found.Lot 12203 is within the bounding of the 2018 linx recall.

Manufacturer Narrative

(b)(4).Date sent: 11/21/2019.Additional information: upon review it was identified that this is a duplicate report.All reported information for this event was reported under 3008766073-2019-00420.

• 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: 9131637
• MDR Text Key: 166398022
• Report Number: 3008766073-2019-00483
• 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: 09/13/2019

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: 09/15/2020
• Device Catalogue Number: LXMC14
• Device Lot Number: 12203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/09/2019; 11/21/2019
• Supplement Dates FDA Received: 10/09/2019; 11/21/2019
• Patient Sequence Number: 1
• Patient Age: 70 YR