MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-19 for 1.5T LINX, 13B LXMC13 manufactured by Torax Medical, Inc..
[186753253]
(b)(4). Date sent: 03/19/2020. 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. What was the reason for removal of the linx device? Were you present during the explant procedure? What is the lot no. For the linx device? Does the patient have any of the allergies to metals? If so, what test have been done to test for metal allergies. Is the patient currently taking currently taking steroids / immunization drugs? Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? Was there any hiatal or crural repair done at the same time as the implant? Was mesh used at time of implant? At the time of removal, was the device found in the correct position/geometry at the time of removal? Have the symptoms resolved since the device was explanted?
Patient Sequence No: 1, Text Type: N, H10
[186753254]
It was reported that a linx device was explanted on (b)(6) 2020 for an unspecified reason. The case was completed with a nissen fundoplication with no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00048 |
| MDR Report Key | 9855867 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-19 |
| 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, 13B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-19 |
| Model Number | LXMC13 |
| Catalog Number | LXMC13 |
| 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 | 2020-03-19 |