MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-25 for NEURX DIAPHRAGM PACING SYSTEM 20-0045 manufactured by Synapse Biomedical Inc.
[3901568]
The pt is a (b)(6) male with als with chronic respiratory failure with mip of 40 and fvc of 55 percent predicted. On fluoroscopy, he had bilateral movement of his diaphragm. He met the indications for diaphragm pacing placement. Past medical history includes copd from smoking (quit 1985) and hypertension. Family medical history is significant for father having deep vein thrombosis with pulmonary embolism. Pt also had some dysphagia and with declining fvc, the plan was for diaphragm pacing with gastrostomy tube placement. The pt underwent an uneventful surgery on (b)(6). He had prophylaxis for deep vein thrombosis with both venodyne boots and subcutaneous heparin. The pt was discharged on post operative day 1. He became suddenly short of breath and was evaluated in the emergency room on (b)(6) and was found to have multiple filling defects bilaterally in the pulmonary arteries. There was also evidence of some heart strain on ct and elevated troponin from demand ischemia in setting of extensive pulmonary embolism. Pt was started on heparin and supported in the icu with oxygen and non-invasive ventilation. He was found to have a femoral clot. Vascular surgery was consulted and they recommended placement of a caval filter to prevent a second pulmonary embolism in a compromised pt. The pt and family declined this therapy. The pt also had an elevated wbc and was considered to have aspiration pneumonia. He was started on broad spectrum antibiotics. He also developed atrial fibrillation with rapid ventricular response that was managed medically. The pt was medically managed initially but became progressively hypercarbic with pco2 elevating even on noninvasive ventilation. The family and pt declined further invasive ventilation even with the possibility of recovering from this event of pulmonary embolism with further complication of pneumonia. They started comfort care only and stopping all therapies. He expired on (b)(6) 2013. Source of information was blinded hospital records and ae report.
Patient Sequence No: 1, Text Type: D, B5
[11376203]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005868392-2013-00002 |
| MDR Report Key | 3444930 |
| Report Source | 05 |
| Date Received | 2013-10-25 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-07-13 |
| Date Mfgr Received | 2013-08-01 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2013-11-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK BARBUTES, DIR |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 44074 |
| Manufacturer Country | US |
| Manufacturer Postal | 44074 |
| 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 LAPAROSCOPIC |
| Product Code | OIR |
| Date Received | 2013-10-25 |
| Model Number | 20-0045 |
| Lot Number | 20-0045-052013-10-9 |
| Device Expiration Date | 2013-11-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNAPSE BIOMEDICAL INC |
| Manufacturer Address | OBERLIN OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-10-25 |