MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Overdose (1988); Seizures (2063)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient took a "boat load" dose of lamictal medication due to experiencing more seizures.Patient underwent mri as the physician was concerned about the lamictal levels.Additional information was received from the neurologist that there is a good chance that patient will not survive this suicide attempt (overdose of medication).No additional relevant information has been received.

Manufacturer Narrative

Describe event or problem, corrected data: the following statement was inadvertently not included in the initial report: "it was reported that the patient took a "boat load" dose of lamictal and onfi medication due to experiencing more seizures.Patient underwent mri as the physician was concerned that the lamictal and onfi had done damage.".

Event Description

It was reported that the patient took a "boat load" dose of lamictal and onfi medication due to experiencing more seizures.Patient underwent mri as the physician was concerned that the lamictal and onfi had done damage.A review of the manufacturer's programming system database found that system diagnostics were within normal limits after the event occurred.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 5880910
• MDR Text Key: 52274659
• Report Number: 1644487-2016-01847
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2017
• Device Model Number: 106
• Device Lot Number: 4397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR