MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-17 for LXC13 LXC-[13] manufactured by Torax Medical, Inc..
[186546310]
(b)(4). Date sent: 03/17/2020. Additional information received: have been prescribed nausea, spasm & heart burn medicines. Had egd w/bravo ph testing performed since 2016 & just had an egd on (b)(6) 2020. Chest pain, fullness in throat area which enables food and liquids to go down, rejuration 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. Have the symptoms improved with the taking of the prescribed medications? What are the next steps recommended for this patient?
Patient Sequence No: 1, Text Type: N, H10
[186546311]
It was reported that linx implant device. Reports having pain, difficulty swallowing with water. A lot of tightness in the chest area, nausea and spasms. It is unknown what the next steps are with regards to treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00047 |
| MDR Report Key | 9843653 |
| Report Source | CONSUMER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-17 |
| 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 | LXC13 |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-17 |
| Model Number | LXC-[13] |
| Catalog Number | LXC13 |
| Lot Number | 5028 |
| 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 | 2020-03-17 |