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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problem Seizures (2063)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Attempts for additional information were unsuccessful.

Event Description

It was reported that the patient has been experiencing an increase in seizures.It is unknown if the seizures are above the patient's pre-vns baseline frequency.Attempts to obtain additional information will be made, but no additional information has been received to date.

Event Description

Additional information with device settings were received.The vns duty cycle was adjusted on (b)(6) 2014.

Manufacturer Narrative

Adverse event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being corrected to adverse event.Outcomes attributed to adverse event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being updated to show that intervention was taken.Type of reportable event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being corrected to adverse event.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3657689
• MDR Text Key: 5316664
• Report Number: 1644487-2014-00580
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2012
• Device Model Number: 103
• Device Lot Number: 2877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2010
• 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): Other
• Patient Age: 30 YR