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 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during generator replacement the heartbeat detection did not work after trying several threshold and sensitivity levels.The patient was on rapid cycling settings prior and the surgeon requested that the settings be placed exactly as they were before.The surgeon opted not to further troubleshoot the heartbeat detection issue since the settings desired would not allow the heartbeat detection to be activated.There were no other issues identified with the vns system.Troubleshooting was performed at the patient's follow-up visit.The normal mode, magnet mode, and autostim output currents were programmed off and the duty cycle was programmed to rapid cycling.Diagnostic testing was performed with results within normal limits.Each heartbeat detection settings was attempted; however, was unable to obtain a heart rate.Further troubleshooting was performed by verifying that the wand was held still over the generator site for the duration of testing.The wand battery was sufficient, and there was no difficulty interrogating, programming, or performing diagnostics on the device.The tablet was plugged into the wall outlet during the verify heartbeat detection process because the tablet was not fully charged prior to the appointment.Interrogations were not performed between each detection attempt.No additional relevant information has been received to date.

Manufacturer Narrative

Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event.Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the internal reporting number assigned for the actions for the reported event.Corrected data: this information was inadvertently left off of the previous mfr.Report.

Event Description

Based on the information available to date, the cause for the reported intermittent heart rate detection may be related to the leakage paths on the side of the pcb created by removal of the tab from the pcb during the manufacturing process.

• 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: 5210780
• MDR Text Key: 31082562
• Report Number: 1644487-2015-06345
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

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: 07/13/2017
• Device Model Number: 106
• Device Lot Number: 203424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2015-002-C
• Patient Sequence Number: 1
• Patient Age: 11 YR