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

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problems Muscle Spasm(s) (1966); Pain (1994)

Event Date 12/01/2018

Event Type  malfunction  

Event Description

It was reported by the patient that she had severe pain on the right side of her brain that radiated down through her body into her legs.The patient reported everything twitched and that it was not a seizure.The patient continuously felt like her head was pounding and pain would not go away.The patient did not take medication and saw physician later in the day who stated battery had dropped.The patient stated her and the physician could not understand why her battery had dropped drastically and caused that pain.The patient stated that she stays away from any electronics that may cause accidental magnet stimulation and did not believe this to be the cause of the pain.The tablet data for the generator was received and reviewed by the manufacturer.No battery status indicator was flagged in the data available, which was from approximately half a year prior to the allegation.As no recent data is available, it was unable to be assessed whether the alleged premature depletion was present.A review of device history records revealed that the generator passed quality control inspection prior to distribution.The device was found to have been manufactured using the laser routing process.No additional relevant information has been received to date.

Event Description

It was reported that the patient was referred for vns generator replacement.The patient underwent vns generator replacement surgery due to battery depletion.The explanted generator was received by the manufacturer and is pending product analysis.

Event Description

Additional tablet data for the generator was received and reviewed by the manufacturer.The discrepancy between the diagaccumconsumed values and the battery voltages is an indication that the battery was depleting faster than expected.Generator product analysis was completed.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.No signs of variation in the output signal were observed and the diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications.The battery voltage measured 2.751 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, = no condition.The diagaccumconsumed memory locations revealed that 26.636% of the battery had been consumed.Due to the disparity in the battery voltage and the battery consumption value, the generator case was opened and a visual assessment of the printed circuit board assembly, or pcba, revealed contaminates on the trimmed edge of the pcba.The generator failed several tests after being subjected to a postburn electrical test.After the contaminates were removed from the trimmed edge, the results of the postburn electrical test were as expected.The contamination observed on the trimmed edge of the pcba suggested probable electrical/resistive paths were established between the copper edges on the trimmed edge, which contributed to supply current conditions, resulting in out of specification increased current consumption for both standby and pulsing modes of operation.This may have been the contributing factor for the alleged premature end of life.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8268943
• MDR Text Key: 133849386
• Report Number: 1644487-2019-00126
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2017
• Device Model Number: 106
• Device Lot Number: 203452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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): Other
• Patient Age: 48 YR