MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for NEURX DIAPHRAGM PACING SYSTEM 21-0017-99 manufactured by Synapse Biomedical Inc..
[119151852]
The patient is an active military member stationed in (b)(6). He had a "red streak" from the exit site of his percutaneous implant, which ran up his chest area. He was treated for an infection at a military hospital in (b)(6) where he was given antibiotics. He returned to (b)(6) and the infection continued. He contacted his following physician at the university of (b)(6) where he lives and where his follow up was being done (he was implanted at (b)(6) medical center). His physician instructed him to stop taking the antibiotics and to call him if the infection continued. The infection did not clear up and the patient returned to university of (b)(6) where his physician decided to remove the device. The patient was explanted some time in (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2018-00003 |
| MDR Report Key | 7844352 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2017-02-22 |
| Date Added to Maude | 2018-09-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK BARBUTES |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 44074 |
| Manufacturer Country | US |
| Manufacturer Postal | 44074 |
| Manufacturer Phone | 4407742488 |
| Manufacturer G1 | SYNAPSE BIOMEDICAL INC. |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 44074 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | DIAPHRAGMATIC PACER |
| Product Code | OIR |
| Date Received | 2018-09-04 |
| Model Number | 21-0017-99 |
| Lot Number | 21-0017-99-120716-40 |
| Device Expiration Date | 2018-12-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-04 |