MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2015 that the patient is having an increase in seizures.The patient was implanted in (b)(6) 2015 and is in the process of being titrated up.He is currently up to 1.0 ma.Prior to vns the patient had 1-2 seizures per week.The last few weeks his seizures have been around 3-4 a week.But he stated that he is going to continue the titration process at this point.The physician stated that there have been no medication changes but there may be some stress although when the patient was seen he was not in any stress and denied being stressed.He stated that all diagnostics were within normal limits.The physician is unclear on the cause of the seizures since the only change has been the vns device implantation.At this point though the physician is not sure what the cause of seizures is but may continue titration or disable for a period to see what happens.

• Brand Name: PULSE GEN MODEL 106
• 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: 5333536
• MDR Text Key: 35209682
• Report Number: 1644487-2015-06861
• 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: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/08/2017
• Device Model Number: 106
• Device Lot Number: 203419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• 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: 33 YR