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

Model Number 20-0035

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

Patient Problem Arrhythmia (1721)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

Information obtained thus far was received from the patient's mother, not medical personnel.A tentative plan was made with the mother, upon patient discharge, to have the patient evaluated by one of two possible centers with expertise in the surgical implantation procedure and device management to evaluate the device for potential cardiac interaction.It is not clear, from the information available at this time, if the adverse event was related to device use.

Event Description

The patient experienced a cardiac event that required resuscitation.

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Type of Device: DIAPHRAGMATIC PACING SYSTEM
• Manufacturer (Section D): SYNAPSE BIOMEDICAL INC.; 300 artino street; oberlin OH 44074
• MDR Report Key: 12155402
• MDR Text Key: 264387284
• Report Number: 3005868392-2021-00002
• Device Sequence Number: 1
• Product Code: OIR
• UDI-Device Identifier: 00852184003007
• UDI-Public: 852184003007
• Combination Product (y/n): N
• PMA/PMN Number: H070003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/12/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: 20-0035
• Device Lot Number: 20-0035-070511-10-9
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2011
• 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): Hospitalization; Life Threatening