MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-11 for LINX 1.5 16 BEAD US LXMC16 manufactured by Torax Medical, Inc..
[185662244]
(b)(4). Date sent: (b)(6) 2020. Date of event: unknown, assumed 1st day of month complaint was reported. The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed. Per consulting medical surgeon: spoke with dr. (b)(6) who has known this patient for several years and has a good relationship with her. His work ups to diagnose her new symptomatology have included a marshmallow swallow which demonstrated a functioning linx device and no reflux. She? S also had a ct scan which shows no gastroesophageal issues. Most recently his colleague at the univ of rochester performed an egd which demonstrated no reflux and easy passage of the scope through the linx device. He indicated he would reach out to the patient and attempt to get her to return to the office for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[185662245]
It was reported that a linx implanted on (b)(6) 2018, due to gerd and acid reflux. The patient had the option of having either the linx implant procedure or traditional surgery and chose the linx implant. Starting near the end of (b)(6) of 2019, the patient started experiencing nausea after eating, initially lasting for fifteen minutes and steady getting worse up until (b)(6) of 2019. The patient was also experiencing heartburn and stomach ache. The patient consulted with the nurse practitioner at the heartburn clinic, where her implant doctor resided. The patient was consulting with this office until (b)(6), when after a visit at the er for heart related issues on (b)(6) 2019. The patient visited her implant doctor on (b)(6) 2019, had a barium swallow test and the implant doctor found scar tissue. The doctor recommended the patient eat chicken, to break up the scar tissue. On (b)(6) 2019, the patient experienced vomiting and diarrhea, went to the er and was referred to a gi doctor. The patient attained a referred from her primary doctor, not the implant doctor, to see the gi doctor. The patient saw the gi doctor on (b)(6) 2019, as well as a cardiologist for her heart issues on (b)(6) 2019. An endo-colonoscopy and biopsies were performed and it was determined the patient had developed irritable bowel syndrome. The patient also had a breath test on (b)(6) 2019 and was diagnosed with sibo - small intestinal bacterial overgrowth. The gi doctor referred the patient back to her implant doctor to discuss removal options for the linx device. The patient returned to her implant doctor, with the results, looking to have the linx removed and received push back from the implant doctor. The patient is currently on prilosec and milk of magnesia. There currently aren't any plans to remove the linx device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00044 |
| MDR Report Key | 9820939 |
| Report Source | CONSUMER |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-23 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2020-02-23 |
| Date Added to Maude | 2020-03-11 |
| 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 | LINX 1.5 16 BEAD US |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-11 |
| Model Number | LXMC16 |
| Catalog Number | LXMC16 |
| 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 | 1. Required No Informationntervention | 2020-03-11 |