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

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

It was reported that the patient's seizures are not controlled and that the patient is having more seizures with her vns than she did previously.Patient also reported that her seizure type has changed.She is now having seizure clusters instead of on-off seizures.This has reportedly been occurring for about a year now.Device was checked few weeks prior to the report and all of the diagnostics were normal at that point.Patient is considering having the device removed since it hasn't been helping her seizures.Patient was referred to see surgeon for explant consult.No relevant information was obtained regarding the patient's seizure control.No adjustments in dosing were made at this appointment.No known surgical interventions have occurred to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6562929
• MDR Text Key: 75017424
• Report Number: 1644487-2017-03767
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2011
• Device Model Number: 103
• Device Lot Number: 2590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2010
• 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 Age: 50 YR