MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-08 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[3775242]
The pt was implanted with the device sometime around (b)(6) 2012. The pt also received an intercostal nerve transfer and was unable to use the device until complete recovery from the transfer, about march of 2013 the pt began using the device for approx 8 hours per day. About (b)(6) 2013, the pt complained of feeling the diaphragm pacing "in his heart". The physician has confirmed the pt did not experience vtach with stimulation from the device. Stimulation settings were reduced and the symptoms resolved. On (b)(6) 2013, the physician surgically replaced the electrode that were the source of the stimulation associated with the arrythmia. The pt has resumed using the device without further incident.
Patient Sequence No: 1, Text Type: D, B5
[11153634]
Synapse biomedical was not informed that this pt had been implanted until the initiating incident was reported approx one year after implantation. It was first reported that the pt needed a repair and replacement of electrode leads to relieve pain "in his heart" experienced with stimulation. Assistance from synapse was requested for the repair procedure. Over a period of two months following the procedure, synapse learned that the pt had received an intercostal nerve transfer sometime around the time the synapse device was implanted. Eventually synapse also learned that, in addition to pain, the pt has experienced ventricular tachycardia. Because of the recent (at the time of device implantation) nerve transfer the device was not tested for a cardiac capture per the procedures identified in the surgical instructions for use. Therefore, it went undetected that some of the electrodes were placed in a position that could cause cardiac rhythm interference. The implanting/reporting physician recognizes that, due to the unusual circumstance of a nerve transfer, the tp was not properly tested according to procedures identified in the product labeling at the time of device implantation. This physician is trained and experienced in use of the device and the testing was not overlooked but could not be properly performed due to the nerve transfer. However, the testing should have been performed later, prior to first use of the device. No device defect or malfunction was indicated. Deviation from established procedures due to unusual circumstances appear to be the sole contributing factor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005868392-2013-00001 |
| MDR Report Key | 3410448 |
| Report Source | 05 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-10-07 |
| Date of Event | 2013-05-10 |
| Date Mfgr Received | 2013-07-22 |
| Device Manufacturer Date | 2012-02-09 |
| Date Added to Maude | 2013-11-18 |
| 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 |
| Health Professional | 0 |
| 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 | 0 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | OIR DIAPHGRAGMATIC/PHRENIC NERVE LAPAROS |
| Product Code | HCC |
| Date Received | 2013-10-08 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-020912-7-1 |
| Device Expiration Date | 2013-11-30 |
| Operator | LAY USER/PATIENT |
| 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. Life Threatening; 2. Required No Informationntervention | 2013-10-08 |