MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-03-06 for 1.5T LINX, 17 BEADS LXMC15 LXMC17 manufactured by Torax Medical, Inc..
[185660245]
(b)(4). Date sent: (b)(6) 2020. Date of event: only event year known: 2019. 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. Was the reason for removal of the linx device related to the symptoms that were reported, heartburn, cough, the return of gerd and hiatal hernia? Was ph testing performed prior to explant to confirm recurrent reflux? After implant, was the device initially effective in controlling reflux? When did the recurrent reflux begin? Was there any hiatal or crural repair done at the same time as the implant? Is the device available for return? If yes, please provide the contact name and mailing address for the return kit.
Patient Sequence No: 1, Text Type: N, H10
[185660246]
It was reported, patient came into clinic today with complaint of heartburn, reflux and cough. He had a 1 cm hh shown on his 5-year egd ((b)(6) 2019). Dr. L. Will be scheduling him for a linx removal and partial nissen fundoplication. " patient had a video esophagram in (b)(6) 2019 which showed decreased motility and no hiatal hernia. The explant has not been scheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00042 |
| MDR Report Key | 9799793 |
| Report Source | STUDY |
| Date Received | 2020-03-06 |
| Date of Report | 2019-09-24 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-06 |
| 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 | 1.5T LINX, 17 BEADS |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-06 |
| Model Number | LXMC15 |
| Catalog Number | LXMC17 |
| Lot Number | 5414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-06 |