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

Model Number 105

Device Problem Degraded (1153)

Patient Problem Seizures (2063)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that the patient has been seizure free with vns for years, but has recently experienced an increase in seizures for the past two months.The mother reported that the patient was scheduled for a surgical consult.The patient underwent generator replacement.The explanted generator has not been received for analysis to date.It is unknown whether or not the increase is above the patient's pre-vns baseline frequency.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

It was reported that the seizures were not an increase above the patient's pre-vns baseline frequency.The physician referred the patient for generator replacement due to the battery life at end of service.An implant card was received indicating that the generator was replaced due to ifi - yes.The explanting facility discarded the explanted generator; therefore, no product analysis can be performed.

• 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: 5691446
• MDR Text Key: 46288713
• Report Number: 1644487-2016-01185
• 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,health
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 105
• Device Lot Number: 202454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 32 YR