MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[187022185]
(b)(4). Date sent: 03/19/2020. Additional information was requested and the following was obtained: it was reported that the patient started having gerd symptoms. Was this the only symptom that the patient had which lead to the discovery of the discontinuous device? When did gerd begin? Yes. Gerd symptoms reoccurred around (b)(6) 2019. What was the date of the imaging which showed the discontinuous linx? If available, please share a copy of this imaging. Please send to productcomplaint1@its. Jnj. Com. Please reference (b)(4). An esophagram and chest x-ray performed(b)(6) 2020 demonstrated the discontinuity of the linx device. What is the device lot number? Lot 12929. What is the product code? N/a. Was the device initially effective in controlling reflux? Yes. Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? No. Did the patient undergo an mri since device implant? If so, when was the mri and what strength? No. Did the patient have any other surgeries in the area? No. Was any additional imaging performed since device implant? Does the device appear to be in a continuous annular state in these images? We are interested in establishing a window when the device may have become discontinuous. Please share any additional images. Please refer to attached field experience questionnaire. Last image demonstrating linx intact was esophagram from (b)(6) 2019. Esophagram from (b)(6) 2020 demonstrates discontinuous linx. We will need notification once the linx device is removed on (b)(6) 2020. When and if the linx device is removed, may we ask that the device be returned for analysis? (b)(6). Bmi: 26. 19. Patient gender: male implanting physician: dr. (b)(6). Device size: 14-bead clasp. Lot: 12929. Implant date: (b)(6) 2017. Explant date: currently implanted. Pre-implant testing: barium swallow, ph, egd results: egd/bx ((b)(6) 2015) - moderately severe distal esophageal stricture, esophagitis, hiatal hernia. Esophagram ((b)(6) 2016) - small hiatal hernia with mild gastroesophageal reflux. 5 cm segment of esophageal irregularity in the mid esophagus. Egd/bx ((b)(6) 2016) - 2 cm segment of columnar lining in distal esophagus; hill grade 3 valve, 1 cm hiatal hernia. Additional testing: chest xray ((b)(6) 2017) - immediately post op linx implant; linx device intact. Egd ((b)(6) 2018) - linx slightly below gej; hill grade 1 valve, no esophagitis. 48 hr bravo ((b)(6) 2018) - demeester: 11. 4, 21. 3. Surveillance esophagram ((b)(6) 2019) - no hiatal hernia, no reflux. Linx intact. Surveillance chest xray ((b)(6) 2019) - linx intact. Surveillance egd ((b)(6) 2019) - hill grade 1 valve, linx seen at gej. 96 hr bravo ((b)(6) 2019) - demeester: 218. , 36. 7, 24. 2, 22. 3. Esophagram ((b)(6) 2020) - linx is discontinuous. Chest xray ((b)(6) 2020) - linx is discontinuous. Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? No. 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. Was mesh used at time of implant? No. What was the reason for removal of the linx device? Ongoing gerd symptoms/mild dysphagia.
Patient Sequence No: 1, Text Type: N, H10
[187022186]
It was reported that the patient had an unknown linx implanted on (b)(6) 2017, due to gerd symptoms. The patient started having heartburn on (b)(6) 2019. The patient returned to the hospital, had a radio esophagram and chest x-ray and found the linx device was disconnected. The patient is scheduled to have the linx device removed on (b)(6) 2020 and will have another linx implanted. The linx was part of the recall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00053 |
| MDR Report Key | 9856640 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-05-15 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-19 |
| 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 | UNK LINX MAGNETIC IMPLANT |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-19 |
| Catalog Number | UNK LINX MAGNETIC IMPLANT |
| Lot Number | 12929 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-19 |