MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-30 for LINX 1.5 16 BEAD US LXMC16 manufactured by Torax Medical, Inc..
[178545130]
(b)(4). Date sent: 01/30/2020. The lot was not provided; therefore, the manufacturing record evaluation 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. Prior to linx placement, did the patient have an egd, ph, and manometry studies done? If yes, could you please share the results? It was reported that the stomach had herniated into the linx device. What were the anatomic findings at the time of the explant operation? Was ph testing performed prior to explant to confirm recurrent reflux? After implant, was the device initially effective in controlling reflux? What is the lot number of the linx device? When using the linx sizing device what technique was used to determine the size? 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? Were there any intra-operative complications during implant? Was there any hiatal or crural repair done at the same time as the implant? Were there any other contributing factors that led to the removal of the device other than the reported dysphagia and recurrent reflux? Was the device found in the correct position/geometry at the time of removal? If no, please answer the following three questions. 1. Please describe the position of the linx device at the time of removal. 2. Did it appear that the position of the device had changed since the implant procedure? How was this change observed (intra-operatively at the same time of explant, x-rays, barium swallow, egd)?
Patient Sequence No: 1, Text Type: N, H10
[178545131]
It was reported that the patient had a linx implant on (b)(6) 2018, due to acid reflux. Symptoms were controlled for nine months then the customer started getting dysphagia and recurrent reflux. The patient returned to the same hospital, same doctor, and had an explant on (b)(6) 2020. The doctor noted the stomach had herniated into the linx device. The doctor removed the linx device and performed a toupet and partial wrap. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00018 |
| MDR Report Key | 9649093 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN |
| Manufacturer Phone | 6107428552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINX 1.5 16 BEAD US |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-30 |
| Model Number | LXMC16 |
| Catalog Number | LXMC16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAX MEDICAL, INC. |
| Manufacturer Address | 4188 LEXINGTON AVENUE NORTH SHOREVIEW MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |