MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-10 for 1.5T LINX, 14B LXMC14 manufactured by Torax Medical, Inc..
[174857939]
(b)(4). 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 reason for removal of the linx device? Prior to linx placement, did the patient have an egd, ph, and manometry studies done? If yes, could you please share the results? The product code reported was the lxmc14. Can you please provide the lot number? When using the linx sizing device what technique was used to determine the size? Does the patient have any of the allergies to metals? If so, what test have been done to test for metal allergies. Is the patient currently taking currently taking steroids / immunization drugs? Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? Was there any hiatal or crural repair done at the same time as the implant? Was mesh used at time of implant? At the time of removal, was the device found in the correct position/geometry at the time of removal? Have the symptoms resolved since the device was explanted?
Patient Sequence No: 1, Text Type: N, H10
[174857940]
It was reported that the device was explanted on (b)(6) 2019. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00010 |
| MDR Report Key | 9575720 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2018-05-30 |
| Date Added to Maude | 2020-01-10 |
| 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, 14B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-01-28 |
| Model Number | LXMC14 |
| Catalog Number | LXMC14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-10 |