MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-19 for SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[49910725]
The company's chief medical officer (a physician) spoke to the attending cardiologist at the hospital and they believe that the device may have contributed to some of the arrhythmias observed, which is a known potential device risk, but the device did not contribute to the patient's death.
Patient Sequence No: 1, Text Type: N, H10
[49910726]
The patient was a (b)(6) year old female who suffered a c5-c7 spinal cord injury following surgical resection of a cyst on her spine leaving her with quadriplegia. She was successfully implanted with the diaphragm pacing system (b)(6) 2013. In 2016 the patient's health began to decline and she was hospitalized earlier in the year (precise date(s) unknown) for treatment of sma syndrome due to recent significant weight loss. No cardiac arrhythmias were noted during that stay and the patient was discharged. The patient further declined and was readmitted to the same hospital in (b)(6) 2016 with bilateral pulmonary emboli and hydronephrosis, which were treated. It was noted that when the diaphragm pacer was turned on and she went from positive chest pressure ventilation to negative chest pressure ventilation she consistently developed ventricular couplets and at one point experienced ventricular tachycardia. At that time all diaphragm pacing was discontinued and ventilation was maintained by mechanical ventilation alone through her tracheostomy. An echocardiogram performed at the time showed increased pulmonary pressures consistent with her pulmonary emboli and no pericardial fluid was noted. The patient continued to deteriorate and further arrhythmias were observed. The family then decided to withdraw further support and the patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2016-00002 |
| MDR Report Key | 5804354 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-19 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-06-08 |
| Date Mfgr Received | 2016-06-08 |
| Device Manufacturer Date | 2013-08-08 |
| Date Added to Maude | 2016-07-19 |
| 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 | 3 |
| Brand Name | SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | DIAPHRAGM PACER |
| Product Code | OIR |
| Date Received | 2016-07-19 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-080813-3-2 |
| Device Expiration Date | 2015-04-30 |
| Operator | LAY USER/PATIENT |
| 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 | 2016-07-19 |