MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-01-17 for 1.5T LINX, 14B LXMC14 manufactured by Torax Medical, Inc..
[181958159]
(b)(4). Date sent: 01/17/2020. Additional information received: date started: (b)(6) 2019. Date of site awareness: (b)(6) 2019. Status: ongoing. Intensity: moderate. Anticipated: yes. Treatment: medication, amitriptyline 10 mg daily. Questions: will the device be explanted? No plans to explant. Were there any intra-operative complications during implant? No. Was there any hiatal or crural repair done at the same time as the implant? Yes, hiatal hernia repair. Had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? No testing done. Did they have an autoimmune disease? Emr shows a history of psoriasis but current notes do not indicate that this is active. Recent pes state skin is normal, without rashes or lesions. Has the patient been prescribed medication? If yes, why was the medication prescribed? Was the medication prescribed to treat the dysphagia, gerd, etc. Were they taking this medication prior to implant? (b)(6) 2019 (at hospital discharge post-implant) ondansetron 4-8mg q 8hrs prn. (b)(6) 2019 amitriptyline 10mg qd at bedtime. Prescribed for esophageal spasm. Not currently taking nexium as was prior to implant. Are they currently taking steroids / immunization drugs? No.
Patient Sequence No: 1, Text Type: N, H10
[181958160]
It was reported that the patient experienced, dysphagia. Subject with long time severe reflux, heartburn and dysphagia pre-op. At 3-week post-op visit c/o pain and heartburn when swallowing solids. Also complains of nausea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00014 |
| MDR Report Key | 9601103 |
| Report Source | STUDY |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2018-11-29 |
| Date Added to Maude | 2020-01-17 |
| 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, 14B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-17 |
| Catalog Number | LXMC14 |
| Lot Number | 24157 |
| 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 | 2020-01-17 |