MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-11-24 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[15115905]
Following surgical implantation of the neurx diaphragm pacing system on (b)(6) 2014, 2-3 hours post implant surgery the patient was returned to the operating room for internal bleeding. Per a surgical report obtained from the site, the implantation of the electrodes was uneventful. There was no bleeding. In the recovery room, the patient's blood pressure was erratic, his abdomen became slightly distended and his hematocrit dropped. They returned to the operating room to evaluate presumed bleeding and hemoperitoneum. The blood in the abdomen was removed and it was discovered he was bleeding from a electrode site in the right diaphragm and one electrode from the left diaphragm was out. A suture was placed in the bleeding artery and the diaphragm, which stopped the bleeding. The free-floating electrode from the left diaphragm was removed and a new electrode was placed. The bleeding was stopped and all electrodes functioned properly. The patient was stable, blood pressure was table and the patient returned to the recovery room in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2014-00002 |
| MDR Report Key | 4283602 |
| Report Source | 05,06,07 |
| Date Received | 2014-11-24 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-10-22 |
| Date Mfgr Received | 2014-10-22 |
| Device Manufacturer Date | 2014-08-28 |
| Date Added to Maude | 2014-12-01 |
| 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 |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 440740000 |
| Manufacturer Country | US |
| Manufacturer Postal | 440740000 |
| Manufacturer Phone | 4407742488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Product Code | OIR |
| Date Received | 2014-11-24 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-082814-2-2 |
| Device Expiration Date | 2014-12-31 |
| 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 | 300 ARTINO STREET OBERLIN OH 44074000 US 44074 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-24 |