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

Model Number 20-0035

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/22/2014

Event Type  Injury  

Event Description

Following surgical implantation of the neurx diaphragm pacing system on (b)(6) 2014, 2-3 hours post implant surgery the patient was returned to the operating room for internal bleeding.Per a surgical report obtained from the site, the implantation of the electrodes was uneventful.There was no bleeding.In the recovery room, the patient's blood pressure was erratic, his abdomen became slightly distended and his hematocrit dropped.They returned to the operating room to evaluate presumed bleeding and hemoperitoneum.The blood in the abdomen was removed and it was discovered he was bleeding from a electrode site in the right diaphragm and one electrode from the left diaphragm was out.A suture was placed in the bleeding artery and the diaphragm, which stopped the bleeding.The free-floating electrode from the left diaphragm was removed and a new electrode was placed.The bleeding was stopped and all electrodes functioned properly.The patient was stable, blood pressure was table and the patient returned to the recovery room in stable condition.

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Manufacturer (Section D): SYNAPSE BIOMEDICAL INC.; 300 artino street; oberlin OH 44074 000
• Manufacturer Contact: mark` barbutes ; 300 artino street; oberlin, OH 44074-0000 ; 4407742488
• MDR Report Key: 4283602
• MDR Text Key: 15115905
• Report Number: 3005868392-2014-00002
• Device Sequence Number: 1
• Product Code: OIR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H070003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: 20-0035
• Device Lot Number: 20-0035-082814-2-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• 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
• Patient Age: 54 YR