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

Model Number	23-0021
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005868392-2022-00002
• Device Sequence Number: 4557535
• Product Code: OIR
• UDI-Device Identifier: 00852184003212
• UDI-Public: 852184003212
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H070003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Replace,Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23-0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male