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

Model Number 103

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

Patient Problems Death (1802); Respiratory Failure (2484)

Event Date 12/10/2015

Event Type  Death  

Event Description

It was reported that the patient passed away.An online obituary search determined the date of death was (b)(6) 2015.Information from the funeral home indicates the cause of death was respiratory failure, but no information was provided on what led to the respiratory failure or the circumstances of death.The relationship of the patient's death to vns therapy is unknown.Review of programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.Based on the limited available information about the patient's death, an internal classification has determined that the death may be possible sudep.The device was explanted, but has not been returned to date.No additional pertinent information has been received to date.

Event Description

The patient's generator and lead were returned to the manufacturer, and product analysis was completed for the generator.Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.Other than findings attributed to the device explant procedure, no visual anomalies were found on the generator.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The internal device data revealed that 59.735% of the battery had been consumed and no anomalies were contained.Analysis of the returned lead is currently underway.No additional pertinent information has been received to date.

Event Description

Product analysis of the patient's returned lead portion was completed.No electrical discontinuities were identified within the returned lead portion.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.No adverse effect was identified on the device performance.Note that since a portion of the lead including the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No additional pertinent information has been received to date.

• 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: 5358583
• MDR Text Key: 35593434
• Report Number: 1644487-2016-00047
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2014
• Device Model Number: 103
• Device Lot Number: 202093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2012
• 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 Outcome(s): Death
• Patient Age: 53 YR