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..
[32747818]
Patient had wires protruding from the skin. Electrodes visible in open wound near sub-xyphoid exit/tunneling point. The electrode was initially tunneled near the skin surface, eventually eroded through the skin, exposing electrode underneath. Surgeon retracted the electrodes from lateral chest area to sub xiphoid region where they were trimmed and reblocked. Patient continues to use dps system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2015-00004 |
| MDR Report Key | 5266871 |
| Date Received | 2015-12-01 |
| Date of Report | 2015-10-27 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2015-10-01 |
| 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 | 20-0045-120511-4-3 |
| Device Expiration Date | 2012-03-31 |
| 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 |