MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Seizures (2063)

Event Date 03/26/2014

Event Type  Injury  

Event Description

It was reported that the vns patient complained of having pain at her right eye and teeth during an office visit on (b)(6) 2014.The patient's device settings were decreased during an office visit on (b)(6) 2014.The patient subsequently reported having an increase in seizures above pre-vns baseline levels during an office visit on (b)(6) 2014.The patient¿s device output current and on-time were increased during this office visit.X-rays were taken during the office visit and reported to be normal.The physician stated that the increase in seizures was related to vns stimulation.Further follow-up revealed that all of the patient¿s seizure types had increased.There was no change to the duration of the patient¿s seizures or post-ictal period.The patient¿s device was reported to be functioning properly and her device off-time had been adjusted since her last office visit.

• Brand Name: PULSE GEN MODEL 104
• 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: 3800629
• MDR Text Key: 4364459
• Report Number: 1644487-2014-01216
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2014

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: 12/31/2013
• Device Model Number: 104
• Device Lot Number: 202011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2012
• 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: 48 YR