MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Pain (1994)

Event Date 05/17/2014

Event Type  Injury  

Event Description

The surgeon reported that the wound was explored and the hematoma was evacuated and the bleeding was controlled.It was reported that the wound was healing at the patient's follow-up appointment.The surgeon reported that the bleeding and hematoma was not directly related to the vns.The hematoma appeared to be related to a bleeding subcutaneous blood vessel.The bleeding around the generator site was believed to be tracked down from the neck wound.

Event Description

It was reported that the recently implanted vns patient was experiencing tenderness in his left neck three days after vns implant.The surgeon found a hematoma that had developed around the patient¿s artery so the patient underwent surgery to suture the artery.During the procedure, the surgeon noted that there was blood around the patient¿s generator.Further follow-up revealed that the patient¿s device was programmed on during an office visit on (b)(6) 2014.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 3889292
• MDR Text Key: 4639167
• Report Number: 1644487-2014-01565
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 103
• Device Lot Number: 202448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2013
• Is the Device Single Use?: Yes
• 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: 57 YR