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 1.5T LINX, 15B LXMC15 manufactured by Torax Medical, Inc..
[185662442]
(b)(4). Date sent: (b)(6) 2020. Date of event: only event year known: 2020. Additional information was requested, and the following was obtained: what was the reason for removal of the linx device? Patient complaining of sporadic dysphagia. Why does the surgeon think that the patient was not a good candidate for the linx device? Inconsistent complaints from patient, works one day, doesn't the next. On what date did the implant take place? On what date did the explant take place? (b)(6) 2020. Was there any hiatal or crural repair done at the same time as the implant? Yes. At the time of removal, was the device found in the correct position/geometry at the time of removal? Yes. What is the lot number for the linx device? Lxmc15. Lot 23773. Does the patient have any of the allergies to metals? No allergy to metal. Is the patient currently taking currently taking steroids / immunization drugs? No. Current steroids or immunosuppressive drugs. Took several weeks of prednisone after linx placement for dysphagia. Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? No preoperative dysphagia. Normal motility on ugi. Egd with erosive esophagitis and 5 cm hiatal hernia. Was mesh used at time of implant? No mesh used. 3 x 2 cm hiatal hernia defect closed with interrupted 0 ethibond sutures. No tension on closure. At the time of removal, was the device found in the correct position/geometry at the time of removal?
Patient Sequence No: 1, Text Type: N, H10
[185662443]
It was reported that the doctor explanted the linx and then performed a nissen fundoplication. The patient has recurrent symptoms and the physician was concerned that the patient was not a good physiological fit for the linx. The doctor did not have to cut the linx device and was able to unclasp it laparoscopically and remove it without incident. There were no other complications. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00057 |
| MDR Report Key | 9897055 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| 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 | 1.5T LINX, 15B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-30 |
| Model Number | LXMC15 |
| Catalog Number | LXMC15 |
| Lot Number | 23773 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-03-30 |