MAUDE Adverse Event Report: SYNAPSE BIOMEDICAL INCORPORATED NEURX DPS; DIAPHRAGM PACING SYSTEM

Model Number	21-0017
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no allegation of a deficiency with the device.The patient did not maintain the electrode exit site as instructed in the ifu.Patient was reminded during a previous encounter to take care of the electrode exit site as instructed in the ifu and did not comply.All indications are that the device operated as intended.
Event or Problem Description
Patient contacted synapse to inform of an abscess at the electrode exit site.During a previous compliant where damaged wires were repaired for this patient, it was noted that the patient was not caring for the exit site as directed in the ifus.Patient was reminded to follow the care instructions for the exit site as detailed in the ifus.Synapse advised patient to contact their surgeon to provide medical guidance on treatment.Patient found a local surgeon who could address the abscess and relocate the electrodes to a new exit site.Surgery was conducted (b)(6) 2025 to relocate the electrodes using ultrasound.Electrode exit site was relocated to a location away from the abscess.A new indifferent electrode was tunneled at the new electrode exit site.Electrodes were crimped with new sockets and placed in new electrode connector.A boot was placed on the connector and filled with silicone, per the ifus.Electrodes were tested and the system functioned properly.

• Brand Name: NEURX DPS
• Common Device Name: DIAPHRAGM PACING SYSTEM
• Manufacturer (Section D): SYNAPSE BIOMEDICAL INCORPORATED; 300 artino street; oberlin OH 44074
• Manufacturer (Section G): SYNAPSE BIOMEDICAL INCORPORATED; 300 artino street; oberlin OH 44074
• Manufacturer Contact: jason fiest ; 300 artino street; oberlin, OH 44074 ; 4407742488
• MDR Report Key: 23423935
• Report Number: 3005868392-2025-00001
• Device Sequence Number: 9863981
• Product Code: OIR
• UDI-Device Identifier: 00852184003144
• UDI-Public: 852184003144
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P200018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 21-0017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Unknown
• Patient Weight: 91 KG