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, 15B LXMC15 manufactured by Torax Medical, Inc..
[174670744]
(b)(4). The lot was not provided; therefore, the manufacturing records 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. Does the surgeon believe that the bowel perforation was not related to the linx device?
Patient Sequence No: 1, Text Type: N, H10
[174670745]
It was reported that the patient had a linx implanted on (b)(6) 2019, due to gerd. At the time of the procedure, the patient has a bowel perforation, which was unrecognized at the time of the procedure. It wasn't known if the patient stayed in the hospital for observation or was discharged. The patient returned, post op, with bowel leakage and infection. The doctor performed an explant on (b)(6) 2019, to remove the linx device, as a precautionary measure, so as not to introduce an additional foreign body in the patient, while the bowel perforation was resolved and healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00011 |
| MDR Report Key | 9575848 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-10 |
| 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, 15B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-10 |
| Model Number | LXMC15 |
| 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 | 2020-01-10 |