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

Model Number 106

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

Patient Problems Chest Pain (1776); Neck Pain (2433); No Code Available (3191)

Event Date 11/13/2017

Event Type  Injury  

Event Description

Report received that a patient had pain at the generator incision site.The physician later indicated that he believed the generator was positioned too laterally.However, there was no indication that it had migrated from its original position.Further information was received that the patient presented with episodes of pain which reportedly spread to the left neck.He also had coughing.Both of these events reportedly occurred with stimulation.The physician indicated that he believed this was indicative of a malfunction of the generator.The patient was referred for surgery, although it was not stated whether it was a planned pocket revision or full vns revision.The vns was turned off.The physician's notes indicated that a "lead test" was performed and results were ok.However, impedance value was not noted.No further relevant information has been received to date.

Event Description

Further information was received that the patient experienced both painful stimulation that occurred "several times a day" and pain in the chest.The physician reportedly did not know whether the generator had migrated.The physician did not know the cause of the pain and painful stimulation and if the two events were related to the possible migration.The impedance value from the clinic visit where the patient first reported the adverse events was provided.It was within normal limits.Further information was received that the patient was seen by the surgeon.The surgeon determined that a revision was not necessary because the main source of the patient's pain was from the stimulation.This was able to be controlled by decreasing the vns pulse width.The surgeon did confirm that the device may have migrated outside of the pocket, but remained in a good place and was not a contributing factor to the painful stimulation.Information from the implanting surgeon indicated that non-absorbable sutures were not used to secure the generator in the pocket at the last replacement.No further relevant information has been received to date.No further relevant intervention has been taken 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: 7102536
• MDR Text Key: 94342711
• Report Number: 1644487-2017-04958
• 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
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2018
• Device Model Number: 106
• Device Lot Number: 204027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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: 58 YR