MAUDE Adverse Event Report: SYNAPSE BIOMEDICAL INC. NEURX DIAPHRAGM PACING SYSTEM; DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR

Model Number 20-0035

Device Problem No Pacing (3268)

Patient Problems Death (1802); Hypoxia (1918); Brain Injury (2219)

Event Type  Death  

Manufacturer Narrative

The device associated with this event was sent directly from the user facility to a certified, independent laboratory ((b)(6)) for testing.The testing was performed in accordance with a protocol provided by synapse biomedical inc.The protocol and summary of the results obtained are provided.The final report has not been completed but will be submitted in a follow-up report, which will contain details for each test conducted.Synapse biomedical inc.Has no further details regarding the adverse event other than those presented in the user facility report.We have had no contact with the patient's family or anyone else directly involved and it should be noted that the patient was not at the user facility at the time of the incident.The only mechanism for device shutdown is a mechanical switch that requires two buttons on the front of the device to be pressed simultaneously.The returned device was found to operate within specifications and the events described in the user facility report could not be reproduced.Manufacture and test records indicate the device was assembled according to controlled, predefined procedures and all testing met specification.There were no errors or deviations found in the device history record nor any indication that the device was defective in any way.A final conclusion will be included with the follow-up report but at this time we have identified no defects with the device, it performs within specifications and we have not be able to reproduce the adverse event as described in the user facility report.

Event Description

The patient was implanted with the synapse biomedical diaphragm pacing system (dps) device (b)(6) 2015.The implanting surgeon contacted a synapse biomedical representative on (b)(6) 2016 reporting that the patient had died.He stated that the mother of the patient had left the patient alone while using the dps and off the mechanical ventilator.When she came back the patient was not breathing and the dps was off.Additional information can be found in user facility report number (b)(4).

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Type of Device: DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR
• 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: 5628922
• MDR Text Key: 44332958
• Report Number: 3005868392-2016-00001
• Device Sequence Number: 1
• Product Code: OIR
• UDI-Device Identifier: 00852184003281
• UDI-Public: (01)00852184003281
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: 20-0035
• Device Lot Number: 20-0035-102815-3-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 20 YR