MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-19 for LXC12 LXC-[12] manufactured by Torax Medical, Inc..
[186548192]
(b)(4). Date sent: 3/19/2020. Date of event: only event year known: 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. The lot was not provided; therefore, the manufacturing record evaluation could not be performed. 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 is the lot number for the linx device? Was ph testing performed prior to explant to confirm recurrent reflux? After implant, was the device initially effective in controlling reflux? When did the recurrent reflux begin? 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 undergo an mri since device implant? If so, when was the mri and what strength? 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.
Patient Sequence No: 1, Text Type: N, H10
[186548193]
It was reported that during an unknown procedure, doctor had explanted a 12-bead linx device from a patient due to sudden re-occurrence of gerd. Doctor believed the device had come apart before the removal case. Doctor did not place another device. It is unknown how the case was completed. There were no patient consequences reported. No other medical intervention was required. Patient is not part of a clinical study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00051 |
| MDR Report Key | 9856532 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-28 |
| 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 | LXC12 |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-19 |
| Model Number | LXC-[12] |
| Catalog Number | LXC12 |
| 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 | 2020-03-19 |