MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-04 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[137798105]
The surgeon believes that the patient's anatomy and body position led to the incident. The patient has an enlarged heart and a highly elevated left diaphragm. When in an upright position it is possible that his organs shifted causing the electrode to contact the heart. Although this was an off-label use of the device and the device was implanted via thoracotomy versus the laparoscopic procedure recommended in the device ifu, it appears the patient's particular anatomy and body position at the time of the incident were the primary contributing factors. Out of caution the physician temporarily discontinued therapy with the dps pending evaluation at a later date.
Patient Sequence No: 1, Text Type: N, H10
[137798106]
The patient experienced ventricular fibrillation during programming of his second external pulse generator (epg) on the day following surgical implantation of the neurx diaphragm pacing system (dps). The patient is a (b)(6) obese male with a paralyzed left diaphragm due to phrenic nerve damage following a thoracic aortic aneurysm on (b)(6) 2018. On (b)(6) 2019 two permaloc electrodes were implanted into the left side diaphragm via thoracotomy along with left phrenic nerve reconstruction. Stimulation was tested at maximum settings while the patient was in the supine position without incident. Initial programming of the epg was performed without discomfort, although the patient was on high post op pain medication. On (b)(6) 2019 settings were being fine-tuned as the patient was then on less pain medication. One epg was left at the settings established the previous day as they were tolerated without discomfort. To establish settings for the second epg the settings were increased to determine the point where the patient would start to feel sensation from stimulation. At this point the patient suddenly became unresponsive and had no pulse. Hospital medical staff started cpr, the patient was intubated and he was transferred to intensive care. He was cardioverted to normal sinus rhythm within about five minutes. On (b)(6) 2019 a fluoroscopy of the heart was performed in an electrophysiology lab. It was observed that one of the electrodes in the diaphragm was pressed against the heart and moved with each beat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2019-00001 |
| MDR Report Key | 8388270 |
| Date Received | 2019-03-04 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-02 |
| Date Mfgr Received | 2019-02-02 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2019-03-04 |
| 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 | 0 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | DIAPHRAGM PACING SYSTEM |
| Product Code | OIR |
| Date Received | 2019-03-04 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-011619-5-1 |
| Operator | HEALTH PROFESSIONAL |
| 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 44149 US 44149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-03-04 |