MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-01 for NEURX DIAPHRAGM PACING SYSTEM manufactured by Synapse Biomedical.
[74431650]
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 | MW5069531 |
| MDR Report Key | 6541159 |
| Date Received | 2017-05-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-04-19 |
| Date Added to Maude | 2017-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | DIAPHRAGM PACER |
| Product Code | OIR |
| Date Received | 2017-05-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNAPSE BIOMEDICAL |
| Manufacturer Address | OBERLIN OH 44074 US 44074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-05-01 |