MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-05 for LXC15 LXC-[15] manufactured by Torax Medical, Inc..
[182230734]
(b)(4). Date sent: 03/05/2020. Only event year known: 2019. 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 provided: implant date: (b)(6) 2013. No intra-operative complications during implant. No hiatal or crural repair done at the time of implant. Linx was surgically removed on (b)(6) 2020.
Patient Sequence No: 1, Text Type: N, H10
[182230735]
It was reported, "in (b)(6) 2013, my gi surgeon tested the symptoms for gerd and determined i was perfect candidate for the linx device. After wearing the device for six years now, recently i've developed pain, irritation, and breathing pressure at the device location on the esophagus. In recent months, my medical providers have performed a ct scan, colonoscopy, endoscopy, esophagram, and fluoroscopic evaluation of esophageal motility. All of these test results found no evidence of other medical issues. Therefore, i'm certain the linx is causing my extremely low quality of life. My gi surgeon is no longer at the hospital. Requesting how to get the linx device removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00038 |
| MDR Report Key | 9792994 |
| Report Source | CONSUMER |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-05 |
| 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 | LXC15 |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-05 |
| Model Number | LXC-[15] |
| Catalog Number | LXC15 |
| Lot Number | 4853 |
| 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 | 1. Required No Informationntervention | 2020-03-05 |