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

Model Number	20-0035
Health Effect - Clinical Codes	Arrhythmia (1721); Death (1802)
Date of Event	06/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The company's chief medical officer (a physician) spoke to the attending cardiologist at the hospital and they believe that the device may have contributed to some of the arrhythmias observed, which is a known potential device risk, but the device did not contribute to the patient's death.
Event or Problem Description
The patient was a (b)(6) year old female who suffered a c5-c7 spinal cord injury following surgical resection of a cyst on her spine leaving her with quadriplegia.She was successfully implanted with the diaphragm pacing system (b)(6) 2013.In 2016 the patient's health began to decline and she was hospitalized earlier in the year (precise date(s) unknown) for treatment of sma syndrome due to recent significant weight loss.No cardiac arrhythmias were noted during that stay and the patient was discharged.The patient further declined and was readmitted to the same hospital in (b)(6) 2016 with bilateral pulmonary emboli and hydronephrosis, which were treated.It was noted that when the diaphragm pacer was turned on and she went from positive chest pressure ventilation to negative chest pressure ventilation she consistently developed ventricular couplets and at one point experienced ventricular tachycardia.At that time all diaphragm pacing was discontinued and ventilation was maintained by mechanical ventilation alone through her tracheostomy.An echocardiogram performed at the time showed increased pulmonary pressures consistent with her pulmonary emboli and no pericardial fluid was noted.The patient continued to deteriorate and further arrhythmias were observed.The family then decided to withdraw further support and the patient expired.

• Brand Name: SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM
• Common Device Name: DIAPHRAGM PACER
• Manufacturer (Section D): SYNAPSE BIOMEDICAL INC.; 300 artino street; oberlin OH 44074
• MDR Report Key: 5804354
• Report Number: 3005868392-2016-00002
• Device Sequence Number: 18929314
• Product Code: OIR
• UDI-Device Identifier: 00852184003007
• UDI-Public: 00852184003007
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: H070003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2016

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 Expiration Date: 04/30/2015
• Device Model Number: 20-0035
• Device Lot Number: 20-0035-080813-3-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2016
• Initial Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR