MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for 1.5T LINX, 14B LXMC14 manufactured by Torax Medical, Inc..
[185660912]
(b)(4). Date sent: (b)(6) 2020. Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What symptoms lead to the discovery of the discontinuous device? When did they begin? What was the date of the imaging which showed the discontinuous linx? If available, please share a copy of this imaging. Was the device initially effective in controlling reflux? Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? Did the patient have any other surgeries in the area? 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. Is the device available for return? If yes, please provide the contact name and mailing address for the return kit.
Patient Sequence No: 1, Text Type: N, H10
[185660913]
It was reported that post implant, a linx was removed by the doctor. Device appears to be separated with weldball visible on end of wire and out of bead case. Egd 12/2019? Small hiatal hernia, device in appropriate location, appears intact. Symptoms of persistent cough and recurring aspiration pneumonia. No mri since implantation. Dor fundo done at time of removal. It is unknown if there were any adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00041 |
| MDR Report Key | 9799734 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-06 |
| 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 | 2020-03-06 |
| Returned To Mfg | 2020-03-10 |
| Model Number | LXMC14 |
| Catalog Number | LXMC14 |
| Lot Number | 8100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-06 |