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

Model Number 106

Device Problems Premature End-of-Life Indicator (1480); Battery Problem (2885)

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

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a medical professional to a company representative that a vns patient¿s generator has had a sudden drop in battery.The battery status indicator was showing 25% on (b)(6) 2016.Review of the dhr for the generator revealed the device met specifications prior to distribution.Systems diagnostics on (b)(6) 2016 were within normal limits.Additional relevant information has not been received to-date.

Event Description

Review of decoded data from the manufacturer¿s in-house programming history database was performed on (b)(6) 2016.Data was available from date of implant, (b)(6) 2015 through (b)(6) 2016.The percent of battery capacity used on (b)(6) 2016 showed 6.451% of the battery had been consumed.The battery voltage on (b)(6) 2016 showed 3.386 volts and an impedance value of 2293 ohms.

Event Description

Review of additional data received was performed as new data was available from the dates (b)(6) 2016, which was the date the physician reported the battery life indicator.The percent of battery capacity used on the latest date available of 10/19/2016 showed 15.774% of the battery had been consumed and the battery voltage showed 2.832 volts and the 25% battery life indicator had been set.

Event Description

Follow-up was received from the company representative that the device had reached the intensified follow-up indicator and the patient had been referred for surgery.No known surgery has occurred to-date.

Event Description

Generator replacement surgery occurred (b)(6) 2017.The explanted device has not been received by the manufacturer to-date.

• 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: 6098291
• MDR Text Key: 60291045
• Report Number: 1644487-2016-02629
• 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,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/21/2017
• Device Model Number: 106
• Device Lot Number: 203437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• 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 Age: 55 YR