MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-10 for 1.5T LINX, 17 BEADS LXMC17 manufactured by Torax Medical, Inc..
[174858493]
(b)(4). Additional information was requested, but unavailable: it was reported that the linx device was to be explanted on (b)(6) 2019. Can you please confirm that this procedure did take place on (b)(6) 2019? Was there any difficulty in removing the device? Prior to linx placement, did the patient have an egd, ph, and manometry studies done? If yes, could you please share the results? When using the linx sizing device what technique was used to determine the size? Did the patient have an autoimmune disease? 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? Was the device found in the correct position/geometry at the time of removal?
Patient Sequence No: 1, Text Type: N, H10
[174858534]
It was reported that the patient had the linx explanted on (b)(6) 2019 due to persistent dysphagia. Interventions: steroid taper, dilations. No other information is known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00006 |
| MDR Report Key | 9574288 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-01-22 |
| Date Added to Maude | 2020-01-10 |
| 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, 17 BEADS |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-10 |
| Catalog Number | LXMC17 |
| Lot Number | 24371 |
| 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 | 2020-01-10 |