MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011); Vomiting (2144)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported from the patient¿s mother that she had to tape the magnet over her daughter¿s device due to coughing despite already decreasing settings and she believes she has pneumonia now.They want to have the device turned off.She also thinks that the battery is low and is misfiring due to this.She also thinks they need to schedule a replacement to get the new device and replace the lead.She states the battery is at about 25%.Notes state that vns lead revision and vns generator/battery replacement is noted.The patient's mother states that she has been coughing and vomiting a great deal and this may have caused some aspiration.She has been coughing hard, to the point of vomiting over the last few days.The coughing has occurred every 1-2 minutes or so and seem to be triggered by activation of her vns implant which activates every 1.1 minutes at current setting.Her parents finally placed the magnet over the vns and have been holding it in place by hand or with tape over the past day to minimize the activations.The magnet has reduced the number of activations, but it is difficult to keep the magnet steady/in place with the patient's movements due to coughing and discomfort.They would like the vns turned off.They report the last time it was interrogated it was at 0-25% battery life and had planned on getting surgery for a replacement vns.They report she has had a vns in place for over 14 years (6 different and several different models/settings).The last vns has been in place around 2 years.Her battery life has typically been shorter than average due to higher duty cycle settings.Device disablement was noted.Replacement referral due to coughing, with vomiting and aspiration as secondary effects.Vns lead revision is also noted but it is unclear if this revision is related to the above adverse events, or if lead revision is actually planned at all for any reason other than contingency.Regarding the pneumonia, there has been no diagnosis of pneumonia from the physician.The mother is assuming based on symptoms.No known surgery has occurred to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8984123
• MDR Text Key: 158889838
• Report Number: 1644487-2019-01753
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2019
• Device Model Number: 104
• Device Lot Number: 5326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 30 YR