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 Neck Pain (2433)

Event Date 04/12/2016

Event Type  Injury  

Event Description

It was reported that a patient was having ear, jaw, and neck pain associated with stimulation.It was reported that the issues may also be psychological in nature.Follow-up to the company representative who was at the patient¿s appointment provided the physician attempted to change her duty cycle settings.It was reported she was in the office for over an hour and didn¿t like that cycle as well.She was still having sharp pain that comes from neck up to her ear and into her jaw, cheek and teeth.She has been to the dentist and her teeth are fine.Diagnostics were performed and were reportedly okay.Generator replacement surgery occurred on (b)(6) 2017.The explanted devices were discarded by the explant facility.Additional relevant information has not been received to-date.

Event Description

Follow-up from the physician provided the full revision was an intervention for the pain reported.

• 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: 6296088
• MDR Text Key: 66342015
• Report Number: 1644487-2017-03121
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2016
• Device Model Number: 103
• Device Lot Number: 4102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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: 40 YR