MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Low Battery (2584)

Patient Problems Pain (1994); Shock (2072)

Event Date 04/25/2016

Event Type  Injury  

Event Description

Clinic notes were received indicating that a vns patient was experiencing painful stimulation (a "shocking" sensation) for which the generator was disabled.It is stated that the painful stimulation stops when someone palms her in the back behind where the vns is placed.It is stated that when it shocks her it shocks her down her arm down to her elbow, in shoulder blade area, up into her neck, head, and teeth.She states that moving her left arm sets it off.The patient was then referred for generator replacement evaluation.Review of available data in the programming and history database revealed no anomalies.A battery life calculation performed with available data indicated the device has 8.5 years remaining until neos = yes although the last 4 years of programming data is missing.Follow up with the provider indicated that the most recent device check was (b)(6) 2016 and when asked for battery status on that date the provider indicated the battery was "failing." the provider indicated that vns was turned off until the battery could be replaced and increase seizure medication was prescribed until vns can be turned back on.The provider stated that the increase in anti-seizure medication was to preclude a serious injury since the vns device had been turned off awaiting generator replacement surgery although the patient had not actually experienced an increase in seizure.Further follow up with the provider indicated that while the clinic notes did not specifically indicate which battery indicator was observed the providers felt the patient's device was at neos or eos.The physician attributed the painful stimulation to the low battery condition and elected to disable the device output for patient comfort reasons.The provider submitted additional clinic notes containing device settings.An updated blc performed based on the newly submitted settings indicated that the device has approximately 8.1 years remaining longevity.No device diagnostic data could be found in the clinic notes therefore the impedance status of the system was unknown.The device was subsequently evaluated and found not to be at eos and had normal lead impedance values in 3 different head/neck positions but the providers elected to proceed with generator replacement surgery on a prophylactic basis.The generator was successfully explanted and replaced on (b)(6) 2016 and normal impedance was observed with the new generator attached to the former lead (dc dc 2).

Event Description

The generator was received for product analysis.During analysis there were no performance or any other type of adverse conditions found with the pulse generator and the generator performed according to functional specifications.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.The pulse generator diagnostics were as expected for the programmed parameters.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The device had not reached an neos or eos condition.No new events have been reported following device replacement.

• Brand Name: PULSE GEN MODEL 102
• 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: 5689538
• MDR Text Key: 46257225
• Report Number: 1644487-2016-01170
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2011
• Device Model Number: 102
• Device Lot Number: 201231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2009
• 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: 37 YR