MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for LINX 1.5T 16 BEAD OUS LXM16 manufactured by Torax Medical, Inc..
[188066183]
(b)(4). Date sent: 03/31/2020. Per photographic evaluation: the provided x-ray image was analyzed by the medical safety officer: "i reviewed a spot upright upper abdominal x ray film depicting an esophagus containing a small column of barium just above an intact linx device. The linx device appears to be above the diaphragm indicating that there is evidence of herniation of the stomach into the chest cavity. " based on this assessment, it doesn't seem that the device migrated from the implant location. Hence, the reported complaint for device migration cannot be confirmed. The dhr for lot 10896 was reviewed. No ncs, defects, or reworks related to the product complaint were found.
Patient Sequence No: 1, Text Type: N, H10
[188066184]
It was reported, lxm16, lot 10896 implanted (b)(6) 2016. The linx was implanted after sleeve surgery. Patient has again reflux issues. X-rays showed that the implant had slipped under the stomach. On (b)(6) 2020 the linx band was explanted. The patient had hiatoplasty fundoplication and gastric bypass. Currently the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00058 |
| MDR Report Key | 9903559 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2020-03-31 |
| 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 1.5T 16 BEAD OUS |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-31 |
| Catalog Number | LXM16 |
| Lot Number | 10896 |
| 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 | 2020-03-31 |