MAUDE Adverse Event Report: SYNAPSE BIOMEDICAL INC. NEURX DIAPHRAGM PACING SYSTEM

Model Number 20-0035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/14/2018

Event Type  Injury  

Event Description

The patient was implanted with the neurx dps device on (b)(6) 2018.The patient remained in the hospital while recovering from concomitant phrenic nerve graft surgery and waiting for placement in a nursing facility.It is policy at the hospital that ventilator dependent patients are on continuous cardiac and pulse/ox monitoring.On (b)(6) 2018 the patient experienced ventricular fibrillation for about 40 seconds.The fibrillation resolved on its own without intervention.

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Type of Device: NEURX DIAPHRAGM PACING SYSTEM
• Manufacturer (Section D): SYNAPSE BIOMEDICAL INC.; 300 artino street; oberlin OH 44074
• Manufacturer Contact: mark barbutes ; 300 artino street; oberlin, OH 44074 ; 4407742488
• MDR Report Key: 7610925
• MDR Text Key: 111388709
• Report Number: 3005868392-2018-00002
• Device Sequence Number: 1
• Product Code: OIR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H070003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 20-0035
• Device Lot Number: 20-0035-040418-2-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 48 YR