MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-28 for 1.5T LINX, 13B LXMC13 manufactured by Torax Medical, Inc..
[181489177]
(b)(4). Date sent: 02/28/2020. 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. 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. Has the patient? S chest tightness resolved since explant?
Patient Sequence No: 1, Text Type: N, H10
[181489178]
It was reported that post-op of a removal of magnetic sphincter augmentation device (linx), patient had linx surgery on (b)(6) 2019. Patient has been experiencing upper chest tightness ever since the implant. Baclofen didn? T help. Patients gerd symptoms have been resolved, but not happy with his experience and wants it out. Surgeon explanted due to this reason. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00036 |
| MDR Report Key | 9769916 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-08-28 |
| Date Added to Maude | 2020-02-28 |
| 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 | 2020-02-28 |
| Returned To Mfg | 2020-03-10 |
| Model Number | LXMC13 |
| Catalog Number | LXMC13 |
| Lot Number | 22957 |
| 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. Required No Informationntervention | 2020-02-28 |