MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Chest Pain (1776); Headache (1880); Neck Pain (2433)

Event Date 02/25/2017

Event Type  Injury  

Manufacturer Narrative

Patient problem :(b)(4).

Event Description

It was reported via clinic notes received by the manufacturer that the patient was in a motor vehicle accident and the vns generator migrated.The patient reported feeling the generator slipping under her arm.The patient reported having headaches that were constant and had worsened overall.The patient continued to utilize her vns for all symptoms, but it was stated that this had not helped with her headaches.The patient reported at an appointment a year following the accident that she felt a shocking pain in her neck.The patient reported that she could feel a wire and continue to complain regarding the generator slipping under her arm and causing constant pain.The patient stated that she feels shocks, which are causing more headaches.The diagnostics were reported as within normal limits.The patient was referred for full vns replacement surgery to address the migration and the painful stimulation.The physician stated that the intervention was to preclude serious injury.The patient underwent replacement surgery.The patient reported following the vns replacement surgery, the patient still feels painful stimulation despite the vns not being programmed on.The physician believed that this may be due to a pinched nerve.The patient was in a motor vehicle accident previously and had neck and back surgery in the past.The physician planned to allow the patient to heal prior to programming the vns back on.The explanted products have not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

During attempts at product return, it was revealed that the facility does not return explanted products without a patient signed release and will not return explanted devices to the manufacturer.

Event Description

It was reported that the patient was referred for a full vns replacement surgery as the pain continued after the previous full replacement surgery.The surgeon recommended no intervention and that the patient give it time.However, the patient presented to a second surgeon stating that the patient's physician had referred her for a full vns replacement surgery.No second relevant surgery in known to have occurred to date.

Event Description

Follow up with the company representative revealed that the second surgeon also informed the patient that there was no intervention needed.It was stated that both surgeons felt it was too early after the previous surgery and that since the patient had a neck injury from her car accident, they wanted to give her time to heal.

• Brand Name: PULSE GEN MODEL 106
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7686856
• MDR Text Key: 113952443
• Report Number: 1644487-2018-01179
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/02/2017
• Device Model Number: 106
• Device Lot Number: 4405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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: 54 YR