MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Electrolyte Imbalance (2196); Seizures, Focal (2260); Therapeutic Response, Decreased (2271)

Event Date 10/28/2014

Event Type  Injury  

Event Description

It was reported by a patient's mother that the patient was having an increase in seizures since his vns replacement surgery on (b)(6) 2014.The patient was hospitalized for a few days in (b)(6) of 2015 for multiple seizures, at which time they found the patient to have low sodium levels, which is a possible, but not confirmed, reason for the increase in seizures.The patient had a few more seizures after the hospitalization, mostly left focal and petite mals.The patient is usually seizure free during the summer months, but he has had seizures during the summer of 2015.The patient had more petite mals and myoclonic jerks that were stopped by swiping his magnet, and they come and go from month to month.The information received from the patient's mother has not been substantiated by the patient's physician(s).No other relevant information has been received to date.

Event Description

Neither of the patient's physicians believed that there was a clear relationship of the change in seizure pattern to vns.The physician's declined to answer any further questions.

• Brand Name: PULSE GEN MODEL 105
• 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: 5001048
• MDR Text Key: 22883797
• Report Number: 1644487-2015-05480
• 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 Family Member or Friend
• Report Date: 07/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 105
• Device Lot Number: 4022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2014
• 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): Hospitalization
• Patient Age: 9 YR