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

Model Number 103

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

It was reported that the patient has experienced a recent and moderate increase in seizures.The physician reported that the patient's mother is placing the patient under an electric blacks and the physician was inquiring if the heat could negatively impact the vns.Attempts to obtain additional relevant information have been unsuccessful to date.It is unknown whether or not the seizures are an increase above the patient's pre-vns baseline frequency.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 4424385
• MDR Text Key: 17947983
• Report Number: 1644487-2015-03623
• 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
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 01/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 8 YR