MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-24 for 1.5T LINX, 17 BEADS LXMC17 manufactured by Torax Medical, Inc..
[180553516]
(b)(4). Date sent: 02/24/2020. 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 reported: the product code was lxmc17. The lot number was 24045. The implant date was (b)(6) 2019. The explant date was (b)(6) 2020. The reason for explant was persistant dysphasia. The patient did not have any mri since being implanted. The surgeon prescribed the patient steroids, but was not effective. The hospital the explant and implant took place was (b)(6) hospital center.
Patient Sequence No: 1, Text Type: N, H10
[180553517]
It was reported that the linx was explanted. Patient had linx surgery on (b)(6) 2019. Patient has been experiencing dysphasia ever since the implant. Steroids didn't help. Surgeon explanted due to this dysphasia. There were no patient consequences reported. Procedure completed laparoscopic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00035 |
| MDR Report Key | 9744727 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2018-11-15 |
| Date Added to Maude | 2020-02-24 |
| 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 | 2020-02-24 |
| Model Number | LXMC17 |
| Catalog Number | LXMC17 |
| Lot Number | 24045 |
| 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 | 1. Required No Informationntervention | 2020-02-24 |