MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-05-26 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[18039785]
Following a surgical procedure to replace the percutaneous electrodes of the neurx diaphragm pacing system, the surgical site of the replacement electrodes had not healed appropriately and the electrodes eroded through the skin. The pt and surgeon opted to return to surgery to clean and repair the surgical site and replace the electrodes again. The surgery was successful and the pt was able to use the dps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2015-00001 |
| MDR Report Key | 4797745 |
| Report Source | 05,06,07 |
| Date Received | 2015-05-26 |
| Date of Report | 2015-05-20 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-01-30 |
| Device Manufacturer Date | 2009-10-06 |
| Date Added to Maude | 2015-05-28 |
| 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 |
| 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 |
| Product Code | OIR |
| Date Received | 2015-05-26 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-100609-2-2 |
| ID Number | UDI (01)00852184003281 |
| Device Expiration Date | 2015-02-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-05-26 |