MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-06 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[185659371]
(b)(4). Date sent: (b)(6) 2020. Date of event: unknown. Device remains implanted. The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Patient Sequence No: 1, Text Type: N, H10
[185659372]
It was reported, (b)(6) old daughter had a linx implant on an unknown date and eight weeks, post op, the daughter is eating six small meals a day and still having little 'heart attacks', esophageal spasms, as well as severe nausea and vomiting. The surgeon will not do any further imaging, testing, radiation or dilation. The surgeon told the mother that the device needs to be removed and the mother indicated that the daughter can't live without it. The daughter has been hospitalized and steroids given but no progress noted, and steroids are due to be tapered starting tomorrow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00039 |
| MDR Report Key | 9799345 |
| Report Source | CONSUMER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | UNK LINX MAGNETIC IMPLANT |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-06 |
| Catalog Number | UNK LINX MAGNETIC IMPLANT |
| 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. Hospitalization | 2020-03-06 |