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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 07/01/2016

Event Type  Injury  

Event Description

It was reported that the patient铠generator was replaced on (b)(6) 2016 due to a burning sensation.Follow up with the offices of the treating neurologist and surgeon clarified the nature of the report.Prior to an appointment on (b)(6) of this year, the patient began experiencing pain over the generator site and neck that coincided with vns stimulation.The pain had started about 2-3 weeks prior to the appointment.Temporarily disabling the device was reported to help alleviate the pain, but it returned when the device was enabled prior to replacement.Device diagnostics were reported to be within normal limits prior to replacement, and no warning messages relating to a potential device issue were delivered.The patient was reported to not able to tolerate an increase in settings due to the pain, although the patient had previously tolerated approximately equivalent settings in the past.The treating physician does not suspect that any contributing trauma or manipulation had preceded the onset of pain.The explanted generator has not been received by the manufacturer to date.No additional pertinent information has been received to date.

Event Description

The explanted generator was received and is currently pending product analysis.

Event Description

Product analysis was completed on the explanted generator.It was noted that the septum was not cored thus eliminating the possibility of a potential unintended electrical current path through body fluids.During analysis the output signal of the generator was monitored for more than 24-hrs and no variations in the output signal or expected level of output current were observed.The generator performed to functional specification.The internal data of the generator was reviewed and it was noted that the last >25% change in impedance value was on (b)(6) 2015.The prechange value was 2455 ohms and the postchange value was 3159 ohms; both of which are within normal limits.

• 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: 6042316
• MDR Text Key: 57916415
• Report Number: 1644487-2016-02401
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2016

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: 02/28/2014
• Device Model Number: 103
• Device Lot Number: 3273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2016; 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2012
• 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: 21 YR