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

Model Number 106

Device Problem Under-Sensing (1661)

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

Event Date 12/05/2016

Event Type  malfunction  

Event Description

It was reported to a company representative that a during implant surgery a surgeon was having difficulty obtaining a heartrate with an aspire generator.The company representative stated that the output current may have been turned on before the heart rate was determined as the surgeon tends to do that to save time, which would interfere with the ability to detect the heartbeat.He provided that he reminded them to make sure the device output is off to evaluate the heart rate as it can cause issues detecting heartrate.Follow-up from the company representative who attended the patient¿s follow-up appointment with the neurologist provided that heartrate detection was active and was working.The device was turned on prior to arriving at the neurology clinic.The diagnostics were reported to be normal.Additional relevant information has not been received to-date.

Event Description

Review of manufacturing records revealed the generator met all specifications prior to distribution.

Event Description

Operative notes were received indicating the device was interrogated and functioning properly at the time of surgery (b)(6) 2016 and the impedance was okay and the device was programmed to previous settings.It also stated that the tachycardia monitoring was interrogated.This was functioning on a setting of #1.The autostimulator was set at 2.5 level of stimulation".Later it was stated the device interrogated appropriately.Lead impedance is okay.However, on notes from a post-operative follow-up (b)(6) 2016, tachycardia monitoring did not pick up his heart rate at a setting of 1, 2, 3, 4, or 5.At the time of the surgical procedure cardiac monitoring/tachycardia monitoring was functioning on a setting of #1.Today tachycardia monitoring was not picking up his heart rate even at a setting of sensitivity of #5.The device was left set at #5." lead impedance was ok.Cardiac monitoring functioning was not detecting his heart rate at a setting of 1, 2, 3, 4, 5.It was left set at #5.

Event Description

A review of the manufacturer¿s in-house programming history database was performed.And revealed data during the implant surgery.The normal mode and magnet mode output current were programmed on prior to the autostimulation and seizure detection parameters being turned on.The diagnostics test was within normal limits.

• 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: 6239216
• MDR Text Key: 64426483
• Report Number: 1644487-2017-03012
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2018
• Device Model Number: 106
• Device Lot Number: 203885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• 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