MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-06 for 1.5T LINX, 17 BEADS LXMC17 manufactured by Torax Medical, Inc..
[178545683]
(b)(4). Date sent: 02/06/2020. Date of event: unknown, assumed 1st day of month that complaint was reported. 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. Additional information was requested, and the following was obtained: do you have the linx product code? Lxmc17 do you have the lot number and serial number (if applicable)? No. On what date was the device implanted? 2018. It was stated that the device was to be explanted on (b)(6) 2019. Was the date incorrect and the date was supposed to be (b)(6) 2020? Yes. On what date was the device explanted? (b)(6) 2020. Were there any intra-operative complications during implant? No. Was there any hiatal or crural repair done at the same time as the implant? No. Please specify the symptoms the patient was experiencing prior to implant (gerd reflux, dysphagia, pain during eating, at night, etc. , )? Gerd/reflux. Please specify the symptoms the patient was experiencing while the device was implanted (gerd reflux, dysphagia, pain during eating, at night, etc. , )? Dysphagia. Had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? If yes, what diagnostic testing was done and have they received the test results? Work up completed by the doctors. Did they have an autoimmune disease? Unknown. Has the patient been prescribed medication? If yes,why was the medication prescribed? Unknown. Was the medication prescribed to treat the dysphagia, gerd, etc. Were they taking this medication prior to implant? Are they currently taking steroids / immunization drugs? Prior to linx placement, did the patient have an egd, ph, and manometry studies done? If yes, could you please share the results? Yes, the patient had the required tests. I do not have access to the results. What is the lot number of the linx device? Unknown. When using the linx sizing device what technique was used to determine the size? Standard training technique. Was the device found in the correct position/geometry at the time of removal? Yes.
Patient Sequence No: 1, Text Type: N, H10
[178545684]
It was reported that the linx device will be explanted on (b)(6) 2019 due to dysphagia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00019 |
| MDR Report Key | 9677647 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-14 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-02-06 |
| 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 | 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, 17 BEADS |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-03-05 |
| Model Number | LXMC17 |
| Catalog Number | LXMC17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2020-02-06 |