MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-21 for 1.5T LINX, 15B LXMC16 LXMC15 manufactured by Torax Medical, Inc..
[178544827]
(b)(4). Date sent: 1/21/2020. 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. The lot was not provided; therefore, the manufacturing record evaluation could not be performed. 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. What was the date of implant? What is the lot number for the lxmc16 linx device? Were there any other contributing factors that led to the removal of the device other than the patient? S anxiety? Does the surgeon believe that there was an alleged deficiency with the linx device? If yes, please explain. Is the patient doing well since removal?
Patient Sequence No: 1, Text Type: N, H10
[178544828]
It was reported that the linx device was explanted on (b)(6) 2019 due to patient anxiety around having the implant. It was originally implanted due to gerd. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00017 |
| MDR Report Key | 9611369 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-01-21 |
| 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, 15B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-21 |
| Model Number | LXMC16 |
| Catalog Number | LXMC15 |
| 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 | 2020-01-21 |