MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-12 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[179311386]
Pc (b)(4). Date sent: 02/12/2020. The lot was not provided; therefore, the manufacturing records evaluation could not be performed. Additional information was requested, and the following was obtained: did the patient experience a post-op device malfunction? No. Patient experiencing bloating. Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? -no did the patient require revision surgery or hardware removal? Yes. Facility name of original implant: b)(6) hospital. Was device explanted? True. Hardware/explant removal due to: bloating. Did patient require revision surgery? True. If yes, date of revision surgery: (b)(6) 2020. Reason for revision surgery: address reflux symptoms. Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? No. Was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: unknown. Patient doing well after surgery is the patient part of a clinical study unknown.
Patient Sequence No: 1, Text Type: N, H10
[179311387]
It was reported that the doctor was doing an explant on (b)(6) 2020 because he thought the stomach had slipped up through the linx device. The patient was presenting with bloating symptoms. The doctor indicated a different doctor had scoped the patient on thursday. The second doctor indicated the patient maybe just had a recurrent hernia. The linx was in the correct position. The stomach did not herniate through the linx. The stomach did herniate into the mediastinum. The first doctor said that it was difficult to reduce but was able to do it. The first doctor removed the linx device and gave the patient a wrap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00025 |
| MDR Report Key | 9703387 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| Catalog Number | UNK LINX MAGNETIC IMPLANT |
| 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 | 2020-02-12 |