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

Model Number 106

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

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

Event Date 06/07/2016

Event Type  malfunction  

Event Description

It was initially reported that the patient was referred for vns generator replacement surgery due to an end of service, or eos, = yes batter status.However, an implant card was later received by the manufacturer indicating that the patient underwent replacement surgery due to pain and migration, which was reported in mfg.Report #1644487-2018-00837.The explanted generator was received by the manufacturer.Generator product analysis was completed.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.The device output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.Due to a disparity between the battery voltage (data in the diagvbat memory locations - 2.787v) and battery consumption value (data in the diagaccumconsumed memory locations - 22.488%) obtained from the ¿as-received¿ decoder download, the pulse generator was opened.With the pulse generator case removed and the battery still attached to the pcba, the battery measured 2.987 volts, an ifi=no condition.The battery was removed.The printed circuit board assembly, or pcba, was subjected to electrical testing.Results showed that the pcba failed several electrical tests, including heartbeat verification and supply current during stimulation and off times.There were observed contaminates on the trimmed edge of the pcba.Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the pcba.After the trimmed edge of the pcba was cleaned, another electrical test was performed.Results were then within normal limits.Based on the electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of specification) for the standby modes of operation, and may have been the contributing factor for the premature battery depletion.No additional relevant information has been received to date.

• 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: 7704803
• MDR Text Key: 114548866
• Report Number: 1644487-2018-01211
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2017
• Device Model Number: 106
• Device Lot Number: 203494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2016
• 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 Age: 55 YR