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

Model Number 23-0021

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Abdominal Pain (1685)

Event Date 06/23/2022

Event Type  malfunction  

Event Description

The patient experienced severe pain on the left side of their diaphragm upon initialization of stimulation with an external pulse generator.Stimulation was repeated with a second external pulse generator and there was no discomfort.

Manufacturer Narrative

Although this incident did not result in serious patient harm, the manufacturer's investigation identified a defect in a defined group of printed circuit boards (pcbs) that are a component of the finished device.Serious harm could result if one of the potential failure modes occurs with one of the affected devices.The defect was introduced at a subcontractor that supplies the pcbs and a supplier corrective action has been initiated.The manufacturer has initiated a recall of affected finished devices and a separate recall report will be submitted to the fda.

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Type of Device: NEURX DPS
• 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: 14939989
• MDR Text Key: 295396280
• Report Number: 3005868392-2022-00002
• Device Sequence Number: 1
• Product Code: OIR
• UDI-Device Identifier: 00852184003212
• UDI-Public: 852184003212
• 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: Nurse Practitioner
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• 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): Other; Required Intervention
• Patient Sex: Male