MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 12/14/2018

Event Type  Death  

Event Description

It was reported that the patient underwent vns implantation surgery a few months previously.Three weeks prior to the initial report, the generator was programmed on.The patient passed away and the cause of death was unknown at the time of the initial report.The physicians did not believe it was related to vns, but the patient's supervisor believed the vns caused the death and the event was being investigated by the police as a result.Follow up with the company representative area revealed that the patient¿s mother found the patient with asystole four days prior to the patient's death.Brain death was diagnosed.The physician believed that the cause of death was sudep.This was provided to the company representative by the police officer investigating the death.An epileptology expert, the police officer, and the company representative were to interrogate the explanted generator.The explanted products have not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

It was stated that a second physician believed that the patient probably had died due to sudep.Data was received from the company representative from the interrogations performed several weeks post-mortem.The tablet data for the generator was reviewed by the manufacturer.The internal generator data indicated that all diagnostics were within normal limits.

Event Description

The explanted products were received by the manufacturer.Lead product analysis was completed.Other than typical wear and explant related observations, no anomalies were identified in the returned lead.The generator is pending product analysis.

Event Description

Generator product analysis was completed.Although the reported allegation of arrhythmia could not be evaluated in the product analysis, or pa, lab, proper functionality of the generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.There was no sign of variation in the output signal and diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.There were no performance or other adverse conditions found with the generator.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8241047
• MDR Text Key: 132836041
• Report Number: 1644487-2019-00039
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2020
• Device Model Number: 106
• Device Lot Number: 204431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/17/2019; 09/11/2019; 10/03/2019
• Supplement Dates FDA Received: 02/11/2019; 09/25/2019; 10/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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): Death
• Patient Age: 19 YR