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

Model Number 20-0035

Device Problem Positioning Problem (3009)

Patient Problem Ventricular Fibrillation (2130)

Event Date 02/02/2019

Event Type  Injury  

Manufacturer Narrative

The surgeon believes that the patient's anatomy and body position led to the incident.The patient has an enlarged heart and a highly elevated left diaphragm.When in an upright position it is possible that his organs shifted causing the electrode to contact the heart.Although this was an off-label use of the device and the device was implanted via thoracotomy versus the laparoscopic procedure recommended in the device ifu, it appears the patient's particular anatomy and body position at the time of the incident were the primary contributing factors.Out of caution the physician temporarily discontinued therapy with the dps pending evaluation at a later date.

Event Description

The patient experienced ventricular fibrillation during programming of his second external pulse generator (epg) on the day following surgical implantation of the neurx diaphragm pacing system (dps).The patient is a (b)(6) obese male with a paralyzed left diaphragm due to phrenic nerve damage following a thoracic aortic aneurysm on (b)(6) 2018.On (b)(6) 2019 two permaloc electrodes were implanted into the left side diaphragm via thoracotomy along with left phrenic nerve reconstruction.Stimulation was tested at maximum settings while the patient was in the supine position without incident.Initial programming of the epg was performed without discomfort, although the patient was on high post op pain medication.On (b)(6) 2019 settings were being fine-tuned as the patient was then on less pain medication.One epg was left at the settings established the previous day as they were tolerated without discomfort.To establish settings for the second epg the settings were increased to determine the point where the patient would start to feel sensation from stimulation.At this point the patient suddenly became unresponsive and had no pulse.Hospital medical staff started cpr, the patient was intubated and he was transferred to intensive care.He was cardioverted to normal sinus rhythm within about five minutes.On (b)(6) 2019 a fluoroscopy of the heart was performed in an electrophysiology lab.It was observed that one of the electrodes in the diaphragm was pressed against the heart and moved with each beat.

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Type of Device: DIAPHRAGM PACING SYSTEM
• Manufacturer (Section D): SYNAPSE BIOMEDICAL INC.; 300 artino street; oberlin OH 44149
• MDR Report Key: 8388270
• MDR Text Key: 137798105
• Report Number: 3005868392-2019-00001
• 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: company representative,health
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 20-0035
• Device Lot Number: 20-0035-011619-5-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 64 YR