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 UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[174858176]
(b)(4). Only event year known: 2019. 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. On what date was the linx device implanted? On what date was the additional surgery to repair the hernia? It was reported that the linx device may have been a lxmc16. Can you please confirm if this is correct? If the linx device was not a lxmc16, was is the correct product code? What is the lot number for the linx device? What was the size of the hernia that was repaired during the original implant procedure? How was the recurrent hernia diagnosed? Did the patient have recurrent symptoms? If yes, please share what symptoms they were experiencing. It was reported that in approximately 6 weeks the patient will have the linx replaced with a wrap? Has this surgery been scheduled? If yes, what is the surgery date? When the linx device is removed we are requesting it be returned for evaluation. Can you please provide contact name and mailing address for the return kit?
Patient Sequence No: 1, Text Type: N, H10
[174858177]
It was reported that unfortunately the patient had a large paraesophageal hernia recur with his linx up in his chest after about 3 weeks. Repaired with interrupted 0 ethibond pledgeted suture and mesh. The patient is stable and unobstructed. Tentative plan per the surgeon is to wait another three weeks, get the patient six weeks out from surgery and redo a possible relaxing incision and likely replace linx with a wrap to provide more bulk in the abdomen. It is unknown what linx size was used for this patient. I believe lxmc16.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00007 |
| MDR Report Key | 9574345 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-16 |
| 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 | UNK LINX MAGNETIC IMPLANT |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-10 |
| Catalog Number | UNK LINX MAGNETIC IMPLANT |
| 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 |