MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for LS13 LS-[13] manufactured by Torax Medical, Inc..
[188065832]
(b)(4). Date sent: 03/30/2020 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? 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? Was the device found in the correct position/geometry at the time of removal? What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? Has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? Please describe and include the dates of the procedures. Are pictures or videos available? How many beads eroded? Where were the eroded beads positioned? Was the patient stented? What is current patient status?
Patient Sequence No: 1, Text Type: N, H10
[188065833]
It was reported that the patient was implanted (b)(6) 2013 with a 13 bead sutured linx device. The patient had complained of dysphagia x 2 months. Upon an upper gi exam on (b)(6) 2020, beads were noted in the esophageal lumen. The entire device was removed via an endoscopic procedure without complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00056 |
| MDR Report Key | 9896895 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-30 |
| 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 | LS13 |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-27 |
| Model Number | LS-[13] |
| Catalog Number | LS13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-30 |