MAUDE Adverse Event Report: SYNAPSE BIOMEDICAL, INC NEURX DPS SYSTEM; DIAPHRAGM PACEMAKER

Model Number 20-0035

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Death (1802); Spinal Cord Injury (2432); Loss Of Pulse (2562)

Event Date 02/03/2016

Event Type  Death  

Event Description

Patient has a c2 spinal cord injury and is ventilator dependent.This diaphragm pacemaker stimulator device was being used at home to give him time off of a ventilator.Mother was allegedly in a different room watching him on a video camera when she noticed he wasn't breathing.When she went into the room she couldn't find a pulse and called 911.He was subsequently declared brain dead.Manufacturer response for diaphragm pacemaker stimulator device, neurx dps system (per site reporter): requested the device be sent to a third party lab for evaluation.

• Brand Name: NEURX DPS SYSTEM
• Type of Device: DIAPHRAGM PACEMAKER
• Manufacturer (Section D): SYNAPSE BIOMEDICAL, INC; 300 artino street; oberlin OH 44074
• MDR Report Key: 5649750
• MDR Text Key: 45001535
• Report Number: 5649750
• Device Sequence Number: 0
• Product Code: OIR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2016
• Device Model Number: 20-0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2016
• Event Location: Home
• Date Report to Manufacturer: 04/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 20 YR