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

Model Number 103

Device Problems Energy Output To Patient Tissue Incorrect (1209); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/22/2017

Event Type  malfunction  

Event Description

It was reported by the physician's office that during the initial interrogation of the patient's vns, he received a message he had not seen before warning that he wanted to increase the output current more than recommended, which obscured the settings.When this message eventually disappeared, the recorded output current was a 0ma and the output current in the reprogram column showed he wanted to change the settings to 2.25ma, which he noted was the patient's output current at her previous interrogation.The physician explained he believed the next 2 settings were also 0ma, with the patient's previously programmed settings showing up in the column.The physician noted he reprogrammed the device and the settings reverted back to the appropriate column and the settings were then as they had been at the last appointment.It was further reported the patient was fine and experienced no issues.

Manufacturer Narrative

Describe event or problem; corrected data: "the patient was referred for generator replacement due to normal battery depletion.The ifi = yes condition (intensified follow-up indicator) was observed by the physician approximately one month prior to the reported unintended settings." this information was inadvertently left off of the initial mfr.Report.

Event Description

The patient was referred for generator replacement due to normal battery depletion.The ifi = yes condition (intensified follow-up indicator) was observed by the physician approximately one month prior to the reported unintended settings.The company representative attended the patient's vns generator replacement surgery and noted the device was completely depleted on the surgery date.She also noted she was able to checked the physician's programming system and found that the system diagnostics showed the device was working as intended.Based on the information received, it is believed that the vns generator had simply further depleted to the pulsedisabled state on the date the physician reported the changed settings.During the pulsedisabled state, the device can still communicate, but has programmed itself to no longer deliver therapy as the battery has depleted.This explains the reason the physician observed that the settings were programmed to 0ma.Additionally, though the generator is disabled and no longer providing therapy (as intended) the battery will continue to deplete normally to the point of no communication.This condition was experienced by the company representative on the date of surgery.No device malfunction is suspected.The device is expected to be returned for analysis, but has not been received to date.

Event Description

The vns generator was received by the manufacturer for analysis.While product analysis is expected, it has not been completed to date.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #1 stated that the ifi = yes condition was observed one month prior to the believed unintended settings.However, the actual information received was that the system diagnostics were normal a month prior to the replacement surgery, and that the ifi = yes indicator was observed by the physician at the time of those system diagnostic test(s).(b)(4).

Event Description

Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device.With the generator opened, no visual anomalies were found on the printed circuit board.During the bench interrogation, the generator was found to be pulse-disabled and at end of service (eos).The circuit board was subjected to electrical testing.All tests required for proper generator function passed.The battery measured 1.929 volts, confirming an eos condition.The cause of the end of service condition was normal current consumption.The internal device data showed that 114.323% of the battery had been consumed.Review of the internal device revealed no anomalies.Other than the expected end of service 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: 6503210
• MDR Text Key: 73120584
• Report Number: 1644487-2017-03640
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2014
• Device Model Number: 103
• Device Lot Number: 3271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2012
• 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: 15 YR