MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 09/15/2015

Event Type  malfunction  

Event Description

Received clinic notes as part of the process for a prophylactic generator replacement referral.Clinic notes dated (b)(6) 2015 report that the patient had alleged that they feel that their seizure frequency has increased since getting the vns.The patient noted that magnets near the vns actually trigger their small seizures rather than reducing them.At this same appointment, the physician noted in their assessment that overall the patient's seizure frequency has been stable for the past 2 years.The physician also programmed the vns output current higher, and noted that the patient appeared to tolerate the adjustment well without adverse effects.There were several appointments following the patient's visit on (b)(6) 2015 where it is noted that the patient's vagal nerve stimulator appeared to be working well.Additionally, the patient had reported using the magnet a couple of times and it seems to be working well for them.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8389561
• MDR Text Key: 137845044
• Report Number: 1644487-2019-00375
• 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: Other
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2014
• Device Model Number: 103
• Device Lot Number: 3391
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2012
• 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: 38 YR