MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 12/07/2015

Event Type  Injury  

Event Description

It was reported that a patient had an increase in seizures, 7-8 seizures per week, which was greater than his previous seizure frequency of 3 seizures per week.The physician referred the patient for generator replacement due to poor seizure control.No surgical intervention has occurred to date.Attempts for further information have been unsuccessful to date.

Event Description

The physician believed that the cause of the increased seizures was due to battery depletion.The increased seizures was below the patient's pre-vns baseline seizure frequency.Diagnostic results were not available from the physician's office.It was reported on (b)(6) 2016 that the patient had prophylactic generator replacement surgery on (b)(6) 2015.The explanting facility's procedures require a patient signature at time of surgery to return product, which was not obtained, so the device was not available for return.

• Brand Name: PULSE GEN MODEL 102
• 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: 5337451
• MDR Text Key: 34743713
• Report Number: 1644487-2015-06872
• 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: 12/07/2015

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: 01/31/2015
• Device Model Number: 102
• Device Lot Number: 202600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2013
• 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: 32 YR