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

Model Number 20-0045

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Erosion (1750)

Event Date 10/01/2015

Event Type  Injury  

Event Description

Patient had wires protruding from the skin.Electrodes visible in open wound near sub-xyphoid exit/tunneling point.The electrode was initially tunneled near the skin surface, eventually eroded through the skin, exposing electrode underneath.Surgeon retracted the electrodes from lateral chest area to sub xiphoid region where they were trimmed and reblocked.Patient continues to use dps system.

• 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: 5266871
• MDR Text Key: 32747818
• Report Number: 3005868392-2015-00004
• Device Sequence Number: 1
• Product Code: OIR
• UDI-Device Identifier: 00852184003281
• UDI-Public: (01)00852184003281
• 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: 10/27/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: 20-0045
• Device Lot Number: 20-0045-120511-4-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2014
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention