MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for LINX 1.5 16 BEAD US LXMC16 manufactured by Torax Medical, Inc..
[186546549]
(b)(4). Date sent: 3/16/2020. 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 was requested, and the following was obtained: have the symptoms resolved since the device was explanted? Yes. On what date did the implant take place? Was the sales rep present during the explant procedure (yes, no, unknown)? Yes does the patient have any of the allergies to metals? If so, what test have been done to test for metal allergies. No. Is the patient currently taking currently taking steroids / immunization drugs? No. Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? No. Was there any hiatal or crural repair done at the same time as the implant? Yes. Was mesh used at time of implant? No. At the time of removal, was the device found in the correct position/geometry at the time of removal? Yes.
Patient Sequence No: 1, Text Type: N, H10
[186546550]
It was reported that the linx device lmxc16 was explanted on (b)(6) 2020 for dysphagia. There were no patient consequences during removal process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00045 |
| MDR Report Key | 9843412 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| 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 | LINX 1.5 16 BEAD US |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-17 |
| Model Number | LXMC16 |
| Catalog Number | LXMC16 |
| Lot Number | 24682 |
| 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 |