MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Failure to Sense (1559)

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

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on 06/22/2016, during the implant surgery, that the m106 impedance was checked and found to be within normal limits.During testing for the tachycardia, the device would not pick up the patient's heart rate.Heart rate detection attempts were made multiple times at on sensitivity settings 1 through 5, the tablet was rebooted, and the wand was tested 3 times.Additionally, the wand was disconnected and re-connected several times.A back up m106 was then opened and implanted.The implanted generator was able to pick up the patient's heart rate right away, and was tested several more times to ensure proper functionality.Review of decoded data shows that on the date of surgery ((b)(6) 2016) for the first m106 generator sn: (b)(4), tachycardia detection was programmed on and sensitivity levels 1-5 interrogation were performed and showed 60 bpm were observed.A system diagnostic test was performed and also showed 60 bpm.All output currents (normal and autostimulation) were programmed off during the testing.The suspect m106 generator was received by the manufacturer for analysis.Analysis is expected but has not been completed to date.

Event Description

Product analysis (pa) for the returned generator was completed.It was noted that in pa, both interrogation and system diagnostics were performed.The device measured 2809 with the test resistor and an ifi = no condition.Communication was ok, and lead impedance, along with current delivered, were normal for all diagnostic tests performed.However, the output waveform, observed from a bench oscilloscope, was abnormal to what is typically observed in the pa lab.In addition, the output waveform voltage measured approximately 3.0v (approximately 4.0v expected ¿ 1ma x 4kohms) and the impedance value (2809 ohms and 2870 ohms) was lower than anticipated (approximately 4000 ohms expected).Additional system diagnostics were performed during the analysis of the generator.The atypical output waveform and diagnostic results were only observed on the first and second system diagnostic tests that were performed in the pa lab.The atypical waveform and diagnostic results were not replicated on any of the system diagnostic tests thereafter.A cause for the initial observations could not be determined; however, it resolved on its own during subsequent diagnostic testing.The stimulus (waveform generator) and the generator were connected to an oscilloscope for visual confirmation of the generator sensing the stimulus.The stimulus was connected to the generator case and out2.Heart beat sensitivity settings 1-5 were evaluated with no load and 2k load conditions between out2 and out1.The generator¿s sensing response observed in the pa lab showed sense delay starts of 2.2 to 3.0 seconds with no load and 2k load conditions.The device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment.The generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The generator diagnostics were as expected for the programmed parameters.The generator was placed in a temperature chamber, which was cycled between 55 degrees celsius and -20 degrees celsius, with a 30 minute dwell at each mad and min limit, for 5 cycles.Heart beat sensitivity setting 5 was evaluated; post temperature cycle, with no load and 2k load conditions between out2 and out1.The generator¿s sensing response observed in the pa lab showed sense delay starts of 3.0 seconds with a no load condition, followed by delays of 11.8 and 2.8 seconds with a 2k load condition.However, the heart beat sensitivity settings 1-5 were re-evaluated, post temperature cycle, with no load and 2k loads between out2 and out1.The generator¿s sensing response observed in the pa lab showed sense delay starts of 2.0 to 3.0 seconds with no load and 2k load conditions.A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications.The generator was opened.Possible contaminates were observed on the trimmed edge of the pcba.Heart beat sensitivity settings 1-5 were evaluated, post open can, with no load and 2k load conditions between out2 and out1.The generator¿s sensing response observed in the pa lab showed sense delay starts between.20 and 2.92 seconds with no load and 2k load conditions.Despite the pcba routed edge observations, no adverse sensitivity delays were encountered during this stage of testing.The battery was removed.The pulse generator module was subjected to a postburn electrical test.Results show that the pulse generator module failed magnet related electrical tests; test:7_9_1, test description: magnet detection normal, value: 0=go, low limit: 0.0, high limit: 0.0, measured: 1.0; 7_9_3, magnet response, 0=go, 0.0, 0.0, 1.0.The magnet detection normal and magnet response test results are due to the need for updates to the test software.The updates will support use of the pa module tab-less test fixture (m105/m106) to help compensate for the distance between the electromagnet coil (on the test fixture) and reed switch (on the pcba).In the meantime, fet (final electrical test) or bench test results will ensure proper reed switch operation.The reported allegation of ¿undersensing no r-wave detected¿, listed in the remetrex issue file, was not duplicated in the pa lab.The pulse generator was instrumented in order to evaluate the delay in producing a heartbeat detection synch pulse.This synch pulse is received by the tablet and used to calculate the heartbeat rate.Test results of the synch pulse in ¿as-received¿ condition yielded sense delays of between 2.2 and 3.0 seconds.Other than the noted event (initial diagnostic test results), there were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 106
• 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: 5815280
• MDR Text Key: 51255183
• Report Number: 1644487-2016-01660
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/20/2016
• Device Model Number: 106
• Device Lot Number: 203795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2016
• 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: 64 YR