MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-12 for NEURX DIAPHRAGM PACING SYSTEM 20-0045 manufactured by Synapse Biomedical Inc..
[15155673]
Pt had the device implanted (b)(6) 2013 and experienced post-operative left pleural effusion and infection causing tachypnea and hypoxemia. He was treated with bipap, o2 and antibiotics. There was no drop in hematocrit and no chest tube needed.
Patient Sequence No: 1, Text Type: D, B5
[15465068]
The initial reporter indicated that the event was not device-related, but it was highly probable that is was related to the implant procedure. The pt was subsequently discharged, but the discharge date is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005868392-2013-00004 |
| MDR Report Key | 3528180 |
| Report Source | 05 |
| Date Received | 2013-12-12 |
| Date of Report | 2013-12-12 |
| Date of Event | 2013-09-24 |
| Date Mfgr Received | 2013-09-26 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2014-01-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK BARBUTES, DIRECTOR - QUAL |
| 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 | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | OIR DIAPHRAGMATIC/PHRENIC NERVE LAPAROS |
| Product Code | OIR |
| Date Received | 2013-12-12 |
| Model Number | 20-0045 |
| Lot Number | 20-0045-112912-10-7 |
| Device Expiration Date | 2013-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNAPSE BIOMEDICAL INC. |
| Manufacturer Address | OBERLIN OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-12-12 |