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

Model Number 103

Device Problem Device Inoperable (1663)

Patient Problem Seizures (2063)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

Information was received indicating that a vns patient had experienced an increase in seizures and reported that the magnet is not working.A battery life calculation was requested which revealed an expected time of 2.9 years until neos would be reached for the patient's device.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information received from the provider indicated that the patient experienced a temporary breakthrough in seizures, attributed the patient's start of menses and birth control medication, on or around (b)(6) 2015.The overall seizure frequency of the breakthrough seizures was back to, but not above, pre-vns level.It was reported that the patient had experienced weight gain (not vns-related) that may have also contributed to the breakthrough seizures in the opinion of the provider.The breakthrough seizures were not related to vns.During the temporary breakthrough seizures the patient experienced one extended duration seizure of 30 min for which the magnet was attempted 14 times but did not abort the seizure.This extended seizure was also attributed to the patient's menses start, birth control medication start with recent weight gain being another possible contributing factor.The extended seizure was not related to vns.On (b)(6) 2015 the patient's vns parameters were changed in an attempt to achieve increased efficacy; normal and magnet output current were each increased one step to 2.25ma and 2.75ma, respectively.Off time was increased from 1.8 min to 3 min.Normal vns function was observed at this visit with diagnostics within normal limits.The provider stated that the patient has not reported any seizures since the (b)(6) visit.It was noted that the patient is on several anti-seizure medications and 2-3 adhd medications and the provider stated belief that birth control medication can negatively impact anti-seizure medication efficacy.

• Brand Name: PULSE GEN MODEL 103
• 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: 4916181
• MDR Text Key: 22390343
• Report Number: 1644487-2015-05181
• 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
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Model Number: 103
• Device Lot Number: 3710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2013
• 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): Other
• Patient Age: 14 YR