MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-06 for LS13 LS-[13] manufactured by Torax Medical, Inc..
[178544989]
(b)(4). Date sent: 2/6/2020. 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. Additional information was requested, and the following was obtained: on what date did the implant take place? (b)(6) 2013. What is the lot number for the ls13? 7221. Was ph testing performed prior to explant to confirm recurrent reflux? Device was removed because of neurologic issue necessitates mri. After implant, was the device initially effective in controlling reflux? Yes. Device was removed because of neurologic issue necessitates mri.
Patient Sequence No: 1, Text Type: N, H10
[178544990]
It was reported that,? Linx, ls13 device was explanted on (b)(6) 2020 due to patient experiencing a return of gerd symptoms. A nissen fundoplication was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00021 |
| MDR Report Key | 9677787 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-06 |
| 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 | LS13 |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-02-06 |
| Model Number | LS-[13] |
| Catalog Number | LS13 |
| Lot Number | 7221 |
| 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 | 2020-02-06 |