MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-30 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedeical Inc..
[78907502]
The manufacturer was notified of the adverse event by the fda. Fda provided information from medwatch report mw5069531 to synapse biomedical via us mail, which was received by the manufacturer on may 30, 2017. The chief medical officer for the manufacturer subsequently contacted the physician treating the patient involved in the adverse event to investigate the potential involvement of the device in the event. It was noted that the device was used off-label in this case to treat an idiopathic diaphragm dysfunction. Both physicians agreed that, because the event occurred three weeks after the implantation surgery, it is unlikely that the event was related to the surgical procedure. Treatment of the patient following the event included a thoracoscopy where the treating physician was able to determine that the implanted electrodes were not (abnormally) protruding through the diaphragm. Based on the information available it does not appear there was a device malfunction or that the device or related implantation surgical procedure contributed directly to the event.
Patient Sequence No: 1, Text Type: N, H10
[78907503]
As reported by the medical facility: pt admitted due to right hemothorax, left sided chest pain emesis, acute blood loss anemia and hypotension. Pt presented to er after having chest pain worse with inspiration which was sudden onset while in the shower on (b)(6) 2017 at 9:15 am. Upon admittance pt still complained of chest pain and had several episodes of emesis. Ct performed in er showing large compressive left complex fluid collection. Physicians drained the fluid via pigtail and sent fluid for analysis which showed no growth after 5 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2017-00001 |
| MDR Report Key | 6682904 |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2017-03-10 |
| Date Added to Maude | 2017-06-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK BARBUTES |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 44074 |
| Manufacturer Country | US |
| Manufacturer Postal | 44074 |
| Manufacturer Phone | 4407742488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | NEURX DPS |
| Product Code | OIR |
| Date Received | 2017-06-30 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-031017-4-2 |
| Device Expiration Date | 2017-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNAPSE BIOMEDEICAL INC. |
| Manufacturer Address | 300 ARTINO STREET OBERLIN OH 44074 US 44074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-06-30 |