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 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the surgeon was unable to detect the patient's heartbeat during the surgical procedure.It was noted that the vns therapy was programmed on while trying to detect the heartbeat.The dhr for m106, sn (b)(4) was reviewed.The dhr was found complete and the m106 passed all testing, including the r-wave verification and the dc leakage-sense delay.Attempts for additional information have been unsuccessful to date.

Event Description

Additional information was received from the surgeon's vns programming system and it was found that the patient's output currents had been programmed on while the surgeon was trying to test the heart beat detection of the device.It should be noted the output currents should be programmed off while trying to test the heart beat detection.Additionally, it can be seen that during a 14 day period, the vns was able to detect 661 times where a stimulation would have been provided, indicating the device was working as expected.

Manufacturer Narrative

Additionally, it can be seen that during a 14 day period, the vns was able to detect 661 times where a stimulation would have been provided, indicating the device was working as expected.This information was inadvertently incorrectly reported on supplemental #01 mfr.Report.This information was inadvertently incorrectly reported on supplemental #01 mfr.Report.

Event Description

It was found during review of the (b)(6) 2016 that two seizures had been detected, but since autostim was programmed to 0ma, not stimulations were delivered.A valid heart ware was detected on (b)(6) 2016 appointment.Attempts for additional relevant information have been unsuccessful to date.

• 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: 5846616
• MDR Text Key: 51976178
• Report Number: 1644487-2016-01744
• 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
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2017
• Device Model Number: 106
• Device Lot Number: 203490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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: 26 YR