MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-09-07 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[2882992]
The pt is a young male who sustained severe chest injuries and had been on positive-pressure mechanical ventilation for over 200 days. A one-time irb approval for an off-label use was obtained to attempt to strengthen the pt's diaphragm and wean him off mechanical ventilation. The pt was using the device on a normal course since surgical implantation on (b)(6) 2012. In a routine check for cardiac rhythm capture during the surgery (per the instructions for use) premature ventricular contractions (pvcs) were detected with the device at maximum stimulation settings. The stimulation settings were adjusted down accordingly and the pvcs were no longer seen. Over the course of the next 20 days the device stimulation parameters were adjusted to resolve pain issues, deal with diaphragm fatigue, and improve hypoventilation at night. This did involve increasing the stimulation parameters although no pvcs or vtach were noted. On (b)(6) 2012, approx 40 minutes after the device was turned on for the night, the pt experienced ventricular tachycardia and ventricular fibrillation. Cpr was performed, cardioversion was done 3 times, and 1 mg of epinephrine was administered to restore normal rhythm. The episode lasted 4 minutes. The device was in use at the time of the incident. The facility considered the event "serious" and "possibly related". It cannot be definitively determined whether the device contributed to the incident or not. The pt completely recovered and has been using the device since the incident at lower stimulation setting without recurrence.
Patient Sequence No: 1, Text Type: D, B5
[10103561]
Because this was an off-label use of the device and a decision was made to increase the stimulation parameters although there was a previously identified susceptibility to cardiac rhythm interference, we do not believe any further action is indicated in response to this incident. The institution and medical professionals involved followed appropriate procedures for an off-label use, including appropriate pt monitoring, in an attempt to help the pt with previously unsuccessful ventilatory weaning. We understand that the pt has weaned from mechanical ventilation and is healthy (previous injuries not withstanding). This appears to be a reasonable practice of medicine with risks appropriately managed and there is no indication of a device malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005868392-2012-00001 |
| MDR Report Key | 2739305 |
| Report Source | 05,07 |
| Date Received | 2012-09-07 |
| Date of Report | 2012-09-06 |
| Date of Event | 2012-07-29 |
| Date Mfgr Received | 2012-08-08 |
| Device Manufacturer Date | 2012-04-17 |
| Date Added to Maude | 2012-09-12 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 44074 |
| Manufacturer Country | US |
| Manufacturer Postal | 44074 |
| Manufacturer Phone | 4407742488 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | OIR DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR |
| Product Code | HCC |
| Date Received | 2012-09-07 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-041712-10-8 |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| 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. Life Threatening; 2. Required No Informationntervention | 2012-09-07 |