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

Model Number 103

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

Patient Problem Dyspnea (1816)

Event Date 10/12/2017

Event Type  Injury  

Event Description

It was reported by a physician (b)(6) 2017 that they were disabling a patient¿s device as the patient has chronic airway obstruction, and it has been getting much worse lately.She does not think that vns is a part of it, but the patient will be getting a tracheostomy, which is also independent of the vns, but she would like to turn the vns off for this procedure, and will titrate the patient back up afterwards.The doctor then mentioned that this patient has been having some vocal cord swelling recently within the past few weeks, which might also be contributing to the intermittent airway problems.It was mentioned that this patient has had airway problems before having his vns implanted, but believes the vns is aggravating the vocal cords, causing them to swell, which may be exacerbating the airway issues for this patient.It was also mentioned that this was the opinion of the patient¿s ent.Additional relevant information has not been received to-date.

Event Description

Follow-up from the provider indicated that the vns stimulation was not causing the vocal cords to swell and the swelling was unrelated to vns.The physician stated they had not done a lead test.The swelling of the vocal cords was indicated to be affecting the patient¿s airway and needed a trach, however the airway effect was independent of the vns.The problem existed prior to vns insertion.

• 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: 7140324
• MDR Text Key: 95581023
• Report Number: 1644487-2017-05068
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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: 06/28/2018
• Device Model Number: 103
• Device Lot Number: 4919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 8 YR