MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-03-31 for 1.5T LINX, 17 BEADS LXMC17 manufactured by Torax Medical, Inc..
[186753282]
(b)(4). Date sent: 03/31/2020. Device remains implanted. Additional information was requested and the following was obtained: what is the internal medicine doctor? S diagnosis of the current symptoms? Response: (b)(6) 2020: clinic visit reflux had resolved. Plan to wean off ppi. 3/26/20: sc spoke w/subject. Face tingling and pain stopped (b)(6) 2020. Esoph spasms 80% better after medrol pack complete, (b)(6) 2020. Unsuccessful weaning from ppi. Now on 20 omeprazole qd w/acceptable symptom control.
Patient Sequence No: 1, Text Type: N, H10
[186753403]
It was reported that the patient on (b)(6) 2020 - er visit for facial pain, headache and nausea/vomiting/diarrhea. Lab work and x-rays done with no concerning findings. Treated w/pain meds and oral steroids. Subject had linx implant (b)(6) 2020. On 2/11/2020 - subject spoke with pi. Symptoms had improved but still with facial pain and esophageal spasms. Pi prescribed hycosamine. (b)(6) 2020 - clinic vs. Facial pain/esophageal spasms only when lying down now. Pi prescribed steroids. Specify medication: hydrocodone/acetaminophen, prednisone, hycosamine. Updated to: torodol, benadryl, prednisone, zofran, compazine - torodol, morphine, benadryl, prednisone, zofran, compazine, hycosamine. Hospitalization: no. Dysphagia - recurrence/pattern: continuous- subject stayed on pre-op omeprazole post- linx implant. At 2 week f/u visit on (b)(6) 2020 subject was having no reflux symptoms so pi had her discontinue. Subject continued to experience heartburn and epigastric pain so on (b)(6) 2020 resumed taking omeprazole. At clinic visit on (b)(6) 2020, subject's reflux had resolved. Pi moved omeprazole dosing to evening with plans to eventually wean off it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00060 |
| MDR Report Key | 9903941 |
| Report Source | STUDY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-08 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-05-20 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Model Number | LXMC17 |
| Catalog Number | LXMC17 |
| Lot Number | 25798 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-31 |