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

Model Number 103

Device Problem Low Battery (2584)

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

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that the patient was experiencing an increase in seizures.The patient's father is concerned that the generator battery is low.The patient was scheduled to see the physician to have the device checked.Attempts to obtain additional relevant information have been unsuccessful to date.It is unknown whether or not the increase is above the patient's pre-vns baseline frequency.

Event Description

It was reported on (b)(4) 2015 that the patient underwent prophylactic generator replacement on (b)(6) 2015.It was reported that the generator could not be returned for product analysis as the hospital does not return explanted devices.

• Brand Name: PULSE GEN MODEL 103
• 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: 4536741
• MDR Text Key: 5505769
• Report Number: 1644487-2015-03947
• 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: Consumer,Company Representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Model Number: 103
• Device Lot Number: 202627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2013
• 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: 28 YR