MAUDE Adverse Event Report: SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM; DIAPHRAGM PACER

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Chest Pain (1776); Hemorrhage/Bleeding (1888); Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Fluid Discharge (2686)

Event Date 04/19/2017

Event Type  Injury  

Event Description

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
• Type of Device: DIAPHRAGM PACER
• Manufacturer (Section D): SYNAPSE BIOMEDICAL; oberlin OH 44074
• MDR Report Key: 6541159
• MDR Text Key: 74431650
• Report Number: MW5069531
• Device Sequence Number: 1
• Product Code: OIR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO CURRENT MEDS PER MEDICAL CHART.
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 100