MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-09 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[174604804]
(b)(4). Even though the event did not take place until (b)(6) 2019, the sales rep was notified about the upcoming explant procedure on 11/15/2019. 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. Prior to linx placement, did the patient have an egd, ph, and manometry studies done? If yes, could you please share the results? On what date did the implant take place? What is the product code for the linx device that was removed? What is the lot number of the linx device? When using the linx sizing device what technique was used to determine the size? Did the patient have an autoimmune disease? Is the patient currently taking steroids / immunization drugs? Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? How severe was the dysphagia/odynophagia before intervention? Were there any intra-operative complications during implant? Was there any hiatal or crural repair done at the same time as the implant? Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? Was the device found in the correct position/geometry at the time of removal?
Patient Sequence No: 1, Text Type: N, H10
[174604805]
It was reported that a linx device was explanted on (b)(6) 2019 because of dysphagia even following dilation. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00005 |
| MDR Report Key | 9571665 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-09 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| 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 | 2020-01-09 |