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

Model Number 103

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

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 02/06/2017

Event Type  Injury  

Event Description

A report was received indicating that a patient had a constant nose bleed that began a day after the patient's vns device settings were changed.The patient was also coughing up blood.The patient's device was programmed off after the bloody nose began by the patient's treating physician.After the device was programmed off the patient's nose continued to bleed.A review of the available programming history showed that the device had historically good impedance values.A review of the device history record for the implanted generator confirmed that it had passed all quality inspections prior to release for distribution.

Event Description

Additional clarifying information was provided from the patient's nurse regarding the bloody nose.The nose bleed had started about 4 days after the patient was programmed up.The nose reportedly began bleeding when the device stimulated.On the patient's next visit, the vns was turned off and the nose bleed came back a few days later.The patient then decided to try stimulation again and was turned back on.The patient's nose was reportedly only bleeding periodically and did not bleed for an entire week, non-stop.All diagnostic results were within normal limits during the clinic visits.The patient had reportedly fallen right before the nosebleed started and the physician believed it may have been related because the patient hit her neck during the fall.The physician also believed the placement of the vns may have been contributing to the nose bleeds.No known surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 6376517
• MDR Text Key: 69010929
• Report Number: 1644487-2017-03310
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/05/2016
• Device Model Number: 103
• Device Lot Number: 202972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2014
• 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 Age: 44 YR