MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-08 for 1.5T LINX, 15B LXMC15 manufactured by Torax Medical, Inc..
[174857551]
(b)(4). Date sent: 01/08/2020. The lot was not provided; therefore, the manufacturing records evaluation could not be performed. Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? Yes. If yes, could you please share the results? What is the lot number of the linx device? When using the linx sizing device what technique was used to determine the size? 3 pop technique. 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? No. Was there any hiatal or crural repair done at the same time as the implant? Yes. Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? No.
Patient Sequence No: 1, Text Type: N, H10
[174857552]
It was reported arrived at the hospital for a linx procedure and discovered the procedure was an explant. The patient, an avid weight lifter, had an lxmc15 linx device implanted three months ago. Device was removed due to terrible dysphagia. The doctor believed the patient's diet requirements for weight lifting (eating lots of protein) made it difficult for the patient to overcome the dysphagia, after the linx device was implanted. The device was removed with no additional reflux procedure performed. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00004 |
| MDR Report Key | 9566794 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-01-08 |
| 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 | 1.5T LINX, 15B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-08 |
| Catalog Number | LXMC15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-08 |