MAUDE Adverse Event Report: SYNAPSE BIOMEDICAL INCORPORATED ELECTRODE DELIVERY TOOL KIT

Model Number	20-0074
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no allegation of a deficiency with the device.All indications are the device operated as intended during the implantation surgery.
Event or Problem Description
This is a new implanting site for use of neurx diaphragm pacing system.The synapse biomedical chief medical officer provided educational support for the site's implanting team.Two operations with implantation of 8 total electrodes were planned and completed on 2 patients.One surgical operation went well with no difficulty with the team.Another more complex patient had an operative bleed requiring returns to the operating room to control the bleeding.The patient in this report of operative bleeding is a complex lung transplant patient who was critically ill with bilateral diaphragm dysfunction still on a ventilator requiring significant respiratory support.Pt was on ecmo because of difficulty with oxygenation.The patient already had a significant retroperitoneal bleed requiring laparotomy from placement of ecmo just days before with drains still in place because of the retroperitoneal oozing.The patient had heparin induced thrombocytopenia(hitt) complicating his post lung transplant course with some extremity losses.It also complicated the anti-coagulation needed for ecmo along with a necessary diaphragm pacing operation to help improve ventilation of his lungs with diaphragm pacing.Patient was on mechanical ventilation, critical life support and drainage catheters both in his chest prior to implantation, along with retroperitoneal drains from previous bleeding.During implantation of the right diaphragm electrodes after successful implantation of left diaphragm electrodes there was bleeding from an arterial vessel on the right diaphragm.Using the electrode delivery tool while placing the electrode between two vessels had bleeding from injury to one of the vessels.No malfunction of the device (electrode delivery tool) was alleged.The bleeding was controlled with suturing and hemostatic agents.The bleeding appeared controlled and surgery completed.Patient was transferred back to the icu in the same critical condition in which he was transferred initially for the surgery.This critical patient with previous bleeding events required two additional trips to the operating room to control bleeding which was eventually controlled.Given his critical events he did recover with eventual weaning from ecmo.He has been having intermittent use of diaphragm pacing fia the synapse biomedical neurx dps to help with his recovery of phrenic and diaphragm dysfunction.On discussion with the implanting surgeon, this patient had a significant risk of morbidity which includes bleeding given his critical nature.The use of the neurx dps in this patient was off label use but there was no other option to try to salvage the patient life and the transplanted lungs.Diaphragm that do not contract lead to significant collapse of the lung.The surgical team acknowledged that this was a higher risk patient, but the benefits had outweighed the risks.The team on that day was successful in 7 other electrode placements, with the electrode delivery tool operating as intended in all 8 electrode placements.Overall bleeding is a known risk of any surgical procedure including diaphragm pacing.We report this because the patient did require further surgical interventions to address operative bleeding.

• Brand Name: ELECTRODE DELIVERY TOOL KIT
• Common Device Name: ELECTRODE DELIVERY TOOL KIT
• Manufacturer (Section D): SYNAPSE BIOMEDICAL INCORPORATED; 300 artino street; oberlin OH 44074
• Manufacturer Contact: jason fiest ; 300 artino street; oberlin, OH 44074 ; 4407742488
• MDR Report Key: 20907080
• Report Number: 3005868392-2024-00001
• Device Sequence Number: 9155652
• Product Code: OIR
• UDI-Device Identifier: 00852184003618
• UDI-Public: 852184003618
• 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
• 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): 12/11/2024

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: Health Professional
• Device Model Number: 20-0074
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 62 YR
• Patient Sex: Male