MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for 1.5T LINX, 14B LXMC14 manufactured by Torax Medical, Inc..
[185659822]
(b)(4). Date sent: (b)(6) 2020. Date of event: only event year known: 2020. Additional information received: confirmed with the coordinator that this is not a discontinuous device but was part of the recall. Esophagram done before explant not cxr. Positive ph bravo study post implant on (b)(6) 2017. Had egd done (b)(6) 2019 and (b)(6) 2020. Device is lxmc-14. Lot 9408 and serial # (b)(4). Removal date (b)(6) 2020. Implanting surgeon dr. (b)(6). Explanting surgeon dr. (b)(6). Date of onset of symptoms (b)(6) 2016 some difficulty swallowing from time to time especially with breads. Or too much water. 6-2019 ct done for abdominal pain and continued difficulty swallowing was the device replaced or a fundoplication done or a dor fundoplication was done same day as removal. Any mris done since the device was implanted back in 2016? Yes one of the brain (b)(6) 2019 but it was with the 1. 5 tesla as that is what his was permitted how? S the patient doing now? Was kept npo for 12 hours after removal, esophogram was done the following day. We have talked to him once since. He is doing as expected. 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? 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 and abdominal pain? Was the device found in the correct position/geometry at the time of removal? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185659823]
It was reported that a linx device was recently removed and she understood it was part of the recall. Implant date of (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00040 |
| MDR Report Key | 9799431 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-11 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2015-10-27 |
| 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 | 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, 14B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-03-05 |
| Model Number | LXMC14 |
| Catalog Number | LXMC14 |
| Lot Number | 9408 |
| Device Expiration Date | 2019-10-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Required No Informationntervention | 2020-03-06 |