MAUDE Adverse Event Report: SYNAPSE BIOMEDICAL INC. NEURX DIAPHRAGM PACING SYSTEM; DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR

Model Number 20-0045

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/27/2015

Event Type  Injury  

Event Description

Patient developed track infection and infection at sub-xyphoid site where implanted over an old scar.Patient also had oozing from electrode block site.It was decided that it would be beneficial for the dps system to be removed before systemic infection could occur.Problems observed in this incident do not appear to be related to any defect with the device.

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Type of Device: DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR
• 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: 5266870
• MDR Text Key: 32748933
• Report Number: 3005868392-2015-00003
• Device Sequence Number: 1
• Product Code: OIR
• UDI-Device Identifier: 00852184003821
• UDI-Public: (01)00852184003821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H100006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2014
• Device Model Number: 20-0045
• Device Lot Number: 20-0045-040414-2-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2014
• 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): Required Intervention