MAUDE Adverse Event Report: SYNAPSE BIOMEDEICAL INC. NEURX DIAPHRAGM PACING SYSTEM; NEURX DPS

Model Number	20-0035
Health Effect - Clinical Codes	Anemia (1706); Chest Pain (1776); Hemothorax (1896); Low Blood Pressure/ Hypotension (1914)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer was notified of the adverse event by the fda.Fda provided information from medwatch report mw5069531 to synapse biomedical via us mail, which was received by the manufacturer on may 30, 2017.The chief medical officer for the manufacturer subsequently contacted the physician treating the patient involved in the adverse event to investigate the potential involvement of the device in the event.It was noted that the device was used off-label in this case to treat an idiopathic diaphragm dysfunction.Both physicians agreed that, because the event occurred three weeks after the implantation surgery, it is unlikely that the event was related to the surgical procedure.Treatment of the patient following the event included a thoracoscopy where the treating physician was able to determine that the implanted electrodes were not (abnormally) protruding through the diaphragm.Based on the information available it does not appear there was a device malfunction or that the device or related implantation surgical procedure contributed directly to the event.
Event or Problem Description
As reported by the medical facility: pt admitted due to right hemothorax, left sided chest pain emesis, acute blood loss anemia and hypotension.Pt presented to er after having chest pain worse with inspiration which was sudden onset while in the shower on (b)(6) 2017 at 9:15 am.Upon admittance pt still complained of chest pain and had several episodes of emesis.Ct performed in er showing large compressive left complex fluid collection.Physicians drained the fluid via pigtail and sent fluid for analysis which showed no growth after 5 days.

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Common Device Name: NEURX DPS
• Manufacturer (Section D): SYNAPSE BIOMEDEICAL INC.; 300 artino street; oberlin OH 44074
• MDR Report Key: 6682904
• Report Number: 3005868392-2017-00001
• Device Sequence Number: 1973139
• Product Code: OIR
• UDI-Device Identifier: 00852184003007
• UDI-Public: (01)00852184003007
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: H070003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: 20-0035
• Device Lot Number: 20-0035-031017-4-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention