MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-18 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[111388709]
The patient was implanted with the neurx dps device on (b)(6) 2018. The patient remained in the hospital while recovering from concomitant phrenic nerve graft surgery and waiting for placement in a nursing facility. It is policy at the hospital that ventilator dependent patients are on continuous cardiac and pulse/ox monitoring. On (b)(6) 2018 the patient experienced ventricular fibrillation for about 40 seconds. The fibrillation resolved on its own without intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2018-00002 |
| MDR Report Key | 7610925 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-05-14 |
| Date Mfgr Received | 2018-05-17 |
| Device Manufacturer Date | 2018-04-04 |
| Date Added to Maude | 2018-06-18 |
| 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 | MARK BARBUTES |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 44074 |
| Manufacturer Country | US |
| Manufacturer Postal | 44074 |
| Manufacturer Phone | 4407742488 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | NEURX DIAPHRAGM PACING SYSTEM |
| Product Code | OIR |
| Date Received | 2018-06-18 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-040418-2-1 |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNAPSE BIOMEDICAL INC. |
| Manufacturer Address | 300 ARTINO STREET OBERLIN OH 44074 US 44074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-06-18 |