MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problem Vomiting (2144)

Event Date 02/23/2016

Event Type  Injury  

Event Description

It was reported that a vns patient had her device switched off for a while due to lack of efficacy.When the device was switched back on, by ramping up the output current from 0.25ma to 0.5ma, the patient vomited.The other device parameters were: pulse width 250 c, signal frequency 20hz, on time 0.7 sec and off time 0.8 min.A company representative suggested to the nurse to drop the pulse width from 250 c to 130 c.The nurse agreed to try that when the patient will be seen again in the clinic.Attempts to obtain additional information were unsuccessful to date.

Manufacturer Narrative

Corrected data: the previously submitted mdr inadvertently provided an incorrect patient information.

Event Description

Further information was received from a nurse, indicating that the event occurred on (b)(6) 2016.It was reported that the device settings were changed back down after the patient vomited; the output current was programmed to 0.25ma.The device was tested and system diagnostics returned impedance results within normal limits with 2602 ohms.It was reported that the patient's device was initially switched off on (b)(6) 2015, because there were no change to the patient's cluster seizures and it was felt that vns was causing breathlessness during sport.The patient asked to switch the device off for 3 months.After that period, the patient was happy to keep it switched off.It was reported that the patient's device was switched back on, on (b)(6) 2016 because the patient's seizures had started to increase.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.No additional information was provided to date.

Event Description

Additional information was provided indicating that the patient was continuing to have problems with vomiting and coughing with stimulation.The patient's settings had been lowered.When the patient was seen for a follow-up visit a few weeks later, the patient's physician opted to slowly program the patient's settings back up.

• Brand Name: PULSE GEN MODEL 103
• 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: 5534086
• MDR Text Key: 41417256
• Report Number: 1644487-2016-00669
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2011
• Device Model Number: 103
• Device Lot Number: 2480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2009
• 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: 28 YR