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

Model Number 102

Device Problems Unexpected Therapeutic Results (1631); Programming Issue (3014)

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

Event Date 01/27/2015

Event Type  malfunction  

Event Description

It was reported on that the vns patient was experiencing an increase in seizures and that magnet mode stimulation was no longer effective in aborting seizures.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.A battery life calculation using the available programming history showed approximately 6.7 years remaining.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Event Description

Further follow-up revealed that at the patient's visit on (b)(6) 2015 the physician indicated that the patient's medication dosages were to be adjusted due to the adverse events.The patient's mother was reluctant to have medication changes made at that time.

• 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: 4532538
• MDR Text Key: 5510745
• Report Number: 1644487-2015-03929
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2011
• Device Model Number: 102
• Device Lot Number: 201269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2009
• 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: 21 YR