MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-03 for NEURX DIAPHRAGM PACING SYSTEM 20-0045 manufactured by Synapse Biomedical Inc..
[4906783]
The clinical site treating the patient reported to the manufacturer on (b)(6) 2014 that the patient had an exit site infection.
Patient Sequence No: 1, Text Type: D, B5
[12328726]
An exit site infection was reported about five an one half months after the surgery to implant the device; therefore, the infection was most likely not related to the surgery. Synapse biomedical believes the infection most likely is related to inadequate exit site cleaning and care. The patient was administered antibiotics and instructions for exit site care were reviewed with the clinical staff in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005868392-2014-00001 |
| MDR Report Key | 4058237 |
| Report Source | 06 |
| Date Received | 2014-07-03 |
| Date of Report | 2014-07-02 |
| Date of Event | 2014-05-31 |
| Date Mfgr Received | 2014-06-02 |
| Device Manufacturer Date | 2013-10-09 |
| Date Added to Maude | 2014-09-08 |
| 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 |
| Generic Name | OIR DIAPHRAGMATIC/PHRENIC NERVE LAPARSCOPICALLY-IMPLANTED STIMULATOR |
| Product Code | OIR |
| Date Received | 2014-07-03 |
| Model Number | 20-0045 |
| Catalog Number | 20-0045 |
| Lot Number | 20-0045-100913-10-10 |
| Device Expiration Date | 2014-06-30 |
| Operator | OTHER |
| 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 44074000 US 44074 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-03 |