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

Model Number 103

Device Problems Premature Discharge of Battery (1057); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2016

Event Type  malfunction  

Event Description

Clinic notes were received in regards to the patient's vns generator replacement referral.Within the clinic notes it was found that the physician had to explain to the patient that this device depleted more quickly than her last device because it had a smaller battery and she was set to higher settings.However, a battery life calculation was performed which showed the generator would still have approximately 1.6 years remaining until neos = yes (near end of service).It should be noted that there is over a year of information that was not available within the manufacturer's internal database which could affect the battery life calculation.The programming history database was reviewed on 10/26/2016.The database contained programming history from 03/10/2014 to 03/16/2015.No anomalies were noted.The diagnostic information showed that the device was performing as intended as the impedance value was within normal limits.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional investigation included a review of the longevity tables found in the physician's manual.The longevity tables for the m103 vns generator showed at settings of 2ma / 20 hz / 500 usec and a 33% duty cycle, the generator would have an estimated 2.6 years from beginning of life to the ifi = yes (intensified follow-up indicator) condition.The patient's device had been se to 2ma / 20 hz / 500 usec and a 35% duty cycle.It is expected that the higher duty cycle would deplete the battery more quickly.Additionally, from date of implant to the date the ifi = yes condition was observed on the patient's device was approximately 2.58 years.This would indicate the battery has depleted as expected.

Event Description

It was reported the patient underwent a vns generator replacement.The explanting facility does not return devices back to the manufacturer; therefore, no product receipt or subsequent analysis is expected.

• 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: 6096710
• MDR Text Key: 60234557
• Report Number: 1644487-2016-02620
• 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,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Model Number: 103
• Device Lot Number: 3747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Clinic - Walk In; Other
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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 Age: 26 YR