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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Seizures (2063)

Event Type  Injury  

Event Description

On (b)(6) 2013, it was reported that the patient's seizures have gotten worse and the patient now has blackouts and questionable syncope.It has been a few years since the patient's vns has been interrogated and the physician stated that she wants the patient to get follow-up with a neurologist, but the patient cannot be seen as she has no insurance.The patient's identifying information was not provided by the physician.Attempts were made for additional information; however, they were unsuccessful.No other information has been received.

Event Description

Additional information was received with patient identifying information.

Event Description

Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Sex, corrected data: previously submitted mdr inadvertently omitted the patient¿s gender.

• Brand Name: PULSE GEN MODEL 102
• 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: 3577589
• MDR Text Key: 4074505
• Report Number: 1644487-2014-00248
• 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: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2007
• Device Model Number: 102
• Device Lot Number: 012081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2005
• 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: 23 YR