MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-01 for NEURX DIAPHRAGM PACING SYSTEM 20-0045 manufactured by Synapse Biomedical Inc..
[32748933]
Patient developed track infection and infection at sub-xyphoid site where implanted over an old scar. Patient also had oozing from electrode block site. It was decided that it would be beneficial for the dps system to be removed before systemic infection could occur. Problems observed in this incident do not appear to be related to any defect with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2015-00003 |
| MDR Report Key | 5266870 |
| Date Received | 2015-12-01 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-02-27 |
| Date Mfgr Received | 2015-04-16 |
| Device Manufacturer Date | 2014-04-04 |
| Date Added to Maude | 2015-12-04 |
| 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 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 | DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR |
| Product Code | OIR |
| Date Received | 2015-12-01 |
| Model Number | 20-0045 |
| Lot Number | 20-0045-040414-2-1 |
| Device Expiration Date | 2014-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNAPSE BIOMEDICAL INC. |
| Manufacturer Address | 300 ARTINO STREET OBERLIN OH 44074 US 44074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-01 |