MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-03 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[44332958]
The device associated with this event was sent directly from the user facility to a certified, independent laboratory ((b)(6)) for testing. The testing was performed in accordance with a protocol provided by synapse biomedical inc. The protocol and summary of the results obtained are provided. The final report has not been completed but will be submitted in a follow-up report, which will contain details for each test conducted. Synapse biomedical inc. Has no further details regarding the adverse event other than those presented in the user facility report. We have had no contact with the patient's family or anyone else directly involved and it should be noted that the patient was not at the user facility at the time of the incident. The only mechanism for device shutdown is a mechanical switch that requires two buttons on the front of the device to be pressed simultaneously. The returned device was found to operate within specifications and the events described in the user facility report could not be reproduced. Manufacture and test records indicate the device was assembled according to controlled, predefined procedures and all testing met specification. There were no errors or deviations found in the device history record nor any indication that the device was defective in any way. A final conclusion will be included with the follow-up report but at this time we have identified no defects with the device, it performs within specifications and we have not be able to reproduce the adverse event as described in the user facility report.
Patient Sequence No: 1, Text Type: N, H10
[44332959]
The patient was implanted with the synapse biomedical diaphragm pacing system (dps) device (b)(6) 2015. The implanting surgeon contacted a synapse biomedical representative on (b)(6) 2016 reporting that the patient had died. He stated that the mother of the patient had left the patient alone while using the dps and off the mechanical ventilator. When she came back the patient was not breathing and the dps was off. Additional information can be found in user facility report number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2016-00001 |
| MDR Report Key | 5628922 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-03 |
| Date of Report | 2016-03-02 |
| Date Mfgr Received | 2016-02-03 |
| Device Manufacturer Date | 2015-10-28 |
| Date Added to Maude | 2016-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR |
| Product Code | OIR |
| Date Received | 2016-05-03 |
| Returned To Mfg | 2016-02-16 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-102815-3-2 |
| Device Expiration Date | 2016-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Death | 2016-05-03 |