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

Model Number 103

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Seizures (2063)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

Clinic notes were received for patient's prophylactic replacement referral due to ifi=yes.Notes mention that the patient feels the device shocking him similar to when his battery has gotten low in the past and seizures are increased in the last 2 weeks.Additional relevant information has not been received.

Event Description

Additional information was received from the neurologist that the patient has experienced neck pain with stimulation several times when the (vns) battery is weakening.The patent has not had more seizures compared to pre-vns baseline level.There were no known changes to medications, vns settings or other external factors which preceded the onset of the increase in seizures.Patient underwent prophylactic generator replacement on (b)(6) 2016 due to ifi - yes.The explanted generator was received on 06/02/2016.Analysis is underway but has not been completed to date.

Event Description

The pulse generator was explanted/returned due to "prophylactic replacement." although the reported allegations of "increased seizures" and "painful stimulation" cannot be evaluated in the pa laboratory setting, 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.This was successfully verified in the pa lab.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generatoroutput signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The reported allegation of "low battery" was not duplicated in the pa lab.The battery, 2.818 volts, shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 5660851
• MDR Text Key: 45340739
• Report Number: 1644487-2016-01047
• 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,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 103
• Device Lot Number: 3999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2014
• 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 Outcome(s): Other
• Patient Age: 29 YR