MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-22 for FENIX CONTINENCE RESTRORATION SYSTEM FS15 NA manufactured by Torax Medical, Inc..
[60742608]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced incontinence (loss of device effectivity) as a result of device exposure to an mri field leading to fenix device explant. The fenix device was used as part of the surgical procedure. Uneventful surgical procedure and device implant on (b)(6) 2016. Uneventful device explant on (b)(6) 2016 due to loss of device effectivity as a result of exposure to an mri field. Although the fenix device is labeled as mri unsafe, the patient did not report any issues during or after the mri other than loss of device effectivity. Immediately after explant the patient was implanted with a replacement fenix device. The device was found in the correct position/geometry at the time of explant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2016-00095 |
| MDR Report Key | 6123002 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-22 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2016-10-27 |
| Device Manufacturer Date | 2012-07-09 |
| Date Added to Maude | 2016-11-22 |
| 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 | MR. DANIEL HOSECK |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN 55126 |
| Manufacturer Country | US |
| Manufacturer Postal | 55126 |
| Manufacturer Phone | 6513618900 |
| Manufacturer G1 | TORAX MEDICAL, INC. |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN 55126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FENIX CONTINENCE RESTRORATION SYSTEM |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | PMH |
| Date Received | 2016-11-22 |
| Returned To Mfg | 2016-11-21 |
| Model Number | FS15 |
| Catalog Number | NA |
| Lot Number | 3736 |
| Device Expiration Date | 2016-07-09 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAX MEDICAL, INC. |
| Manufacturer Address | 4188 LEXINGTON AVENUE N SHOREVIEW MN 55126 US 55126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-11-22 |