MAUDE Adverse Event Report: CYBERONICS, INC. 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 03/01/2016

Event Type  Injury  

Event Description

On (b)(6) 2016 it was reported that the patient has been having "multiple breakthrough seizures" and the physician is considering implanting him with a model 106 generator as he thinks it may help with the patient's seizures, though it was noted that this would be considered a prophylactic replacement.

Event Description

On (b)(6) 2016 it was reported that the patient was scheduled for prophylactic generator replacement on (b)(6) 2016.The clinical reason is that his seizures have increased in number and severity with the current generator.The surgeon has noted heart rate variability in this patient and suggested this new generator model as the "next step".The patient underwent the generator replacement on (b)(6) 2016.The lead impedance for the new implant was ok, 1618ohms.The explanted generator cannot be returned for product analysis per the hospital.

Event Description

The surgeon stated that the increase in seizures and increase in severity of the seizures were not related to vns.They were believed to be due to the patient¿s medicine, drug regimen, and disease progression.

• 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: 5570936
• MDR Text Key: 42440424
• Report Number: 1644487-2016-00780
• 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,Followup,Followup
• Report Date: 03/25/2016

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: 01/31/2015
• Device Model Number: 103
• Device Lot Number: 202602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/12/2016; 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2013
• 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: 46 YR