MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for NEURX DPS SYSTEM 20-0035 manufactured by Synapse Biomedical, Inc.
[45001534]
Patient Sequence No: 1, Text Type: N, H10
[45001535]
Patient has a c2 spinal cord injury and is ventilator dependent. This diaphragm pacemaker stimulator device was being used at home to give him time off of a ventilator. Mother was allegedly in a different room watching him on a video camera when she noticed he wasn't breathing. When she went into the room she couldn't find a pulse and called 911. He was subsequently declared brain dead. Manufacturer response for diaphragm pacemaker stimulator device, neurx dps system (per site reporter): requested the device be sent to a third party lab for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5649750 |
| MDR Report Key | 5649750 |
| Date Received | 2016-05-12 |
| Date of Report | 2016-04-27 |
| Date of Event | 2016-02-03 |
| Report Date | 2016-04-27 |
| Date Reported to FDA | 2016-04-27 |
| Date Reported to Mfgr | 2016-04-27 |
| Date Added to Maude | 2016-05-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DPS SYSTEM |
| Generic Name | DIAPHRAGM PACEMAKER |
| Product Code | OIR |
| Date Received | 2016-05-12 |
| Returned To Mfg | 2016-02-22 |
| Model Number | 20-0035 |
| Device Expiration Date | 2016-04-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| 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 | 2016-05-12 |