MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-01 for NEURX DIAGPHRAGM PACING SYSTEM 20-0045 manufactured by Synapse Biomedical Inc..
[32748621]
Infection in one of the electrode lead tracks. The patient and surgeon opted to cut affected wire and added a wound vac to clear up drainage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2015-00002 |
| MDR Report Key | 5266874 |
| Date Received | 2015-12-01 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-03-18 |
| Device Manufacturer Date | 2012-10-02 |
| 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 DIAGPHRAGM PACING SYSTEM |
| Generic Name | DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR |
| Product Code | OIR |
| Date Received | 2015-12-01 |
| Model Number | 20-0045 |
| Lot Number | 20-0045-100212-10-1 |
| Device Expiration Date | 2013-07-31 |
| 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 |