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

Model Number 103

Device Problems Premature End-of-Life Indicator (1480); Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

It was reported that the patient had generator replacement on (b)(6) 2015, and was seen post-operatively to turn on the replacement device, but a near end of service (neos) message was observed upon interrogation.The surgeon reported that electro-cautery was not used in proximity to the generator during surgery.He felt that the generator was defective.The generator was subsequently replaced the same day.The explanted generator has not been received to date by the manufacturer for analysis.The hospital¿s policy is to keep explanted devices.Good faith attempts for additional, relevant information have been unsuccessful to date.

Event Description

It was reported that the company representative observed end of service vbat < eos message on two different programmers.The hospital registered nurse reported that it is possible that the resident used bovie electrocautery.If electrocautery comes in contact around the generator, this is a known cause for premature end of service of the battery.

Event Description

A copy of the programmer data from the surgery was reviewed.The device was interrogated on date of implant and was set to 1.5ma.The battery status indicator was already revealing near end of service (neos) = yes.It was reported that the device was off at time of implant.Review of the generator device history record was performed and confirmed that all quality specifications were passed prior to distribution.No anomalies were observed during the manufacturer process, and the device was confirmed to be set to 0ma at time of manufacturer release.

Manufacturer Narrative

The user facility medwatch report received was identified to be related to the event previously reported within this manufacturer report which reported the events and device information previously.(b)(4).Based on the investigation, the premature end of life of the generator is suspected asic latch-up as a result of electrocautery during implant surgery.However, a definitive conclusion cannot be made, as the explanted generator was not received by the manufacturer for analysis.Good faith attempts for product return have been unsuccessful.This event is addressed in labeling and is due to asic latch-up.Per section 1.6.4.1 of the vns therapy system physician's manual (u.S.), "use of electrosurgery (electrocautery or radio frequency [rf] ablation devices) may damage the pulse generator.During the vns implantation procedure, do not use electrosurgical equipment after the pulse generator has been introduced to the sterile field.[.] electrostatic discharge (esd) may damage the pulse generator.Care should be taken when using the hex screwdriver to avoid touching the metal shaft when the screwdriver is engaged with the setscrew of the pulse generator.This shaft can serve as a path to conduct electrostatic discharges into the device circuitry.".

Event Description

An user facility medwatch was received on 10/05/2015 reporting an unspecified error during device replacement requiring a second procedure.The medwatch report date was 07/07/2015 via the fda's medwatch program and report # was mw5044181.

• 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: 4874583
• MDR Text Key: 6060142
• Report Number: 1644487-2015-05047
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 103
• Device Lot Number: 202954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 0 DY
• Event Location: Other
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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 Age: 25 YR