MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Sticking (1597)

Patient Problems Septic Shock (2068); Skin Tears (2516)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient has been sick since device was placed.The physician thought it was the medications and changed her medications.Patient stated that she was in the hospital for septic shock from (b)(6) and was in the hospital on (b)(6) 2016.Patient experiences shocking sensations despite holding the magnet over the device.The tape over the magnet is peeling her skin since she has had the magnet in place for 3 weeks and that when she changes the tape it peels her skin.Per the neurologist and primary care physician, patient has permanent ekg changes and electrical conductive problems w/ her heart that is related to the vns device.The patient had a chemical stress test and was in vtach.Patient was given medication to slow her heart rate.Patient would like tc to visit and turn off vns but tcs need physician's written consent to do so and patient has not yet seen their neurologist.Patient was seen by a different neurologist on (b)(6) 2016.Per the nurse at the office, the vns was not evaluated at that time and the device was believed to be off.Additional relevant information has not been received to date.

Event Description

Additional information was received that the patient underwent surgery to have vns generator removed on (b)(6) 2016.Per the surgeon, patient did not have a history of any heart issues or risk factors that makes them more susceptible to heart issues prior to vns implantation.The patient reported that the sepsis was not related to vns therapy.The explanted generator has not been received to date.No other relevant information was received.

Event Description

The explanted generator was returned to the manufacturer.Analysis is underway but has not been completed.

Manufacturer Narrative

(b)(4).

Event Description

Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the lab.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.The pulse generator performed according to functional specifications.There were no performance or any other type of adverse condition found with the pulse generator.

• Brand Name: PULSE GEN MODEL 106
• 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: 5975296
• MDR Text Key: 55566021
• Report Number: 1644487-2016-02185
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2017
• Device Model Number: 106
• Device Lot Number: 203585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 44 YR