MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Seizures (2063); No Code Available (3191)

Event Date 02/23/2015

Event Type  Injury  

Event Description

It was reported that a patient experienced ataxia and had visited the er regarding this following a vns generator replacement surgery.The attending neurologist did not believe this incident to be related to vns and further added that the patient had subclinical seizures and not ataxia.Additional information was received stating that the exact time when patient began having the subclinical seizures is unknown and that it was presumed to be sometime after the vns generator replacement surgery.The subclinical seizures were reported to be a new type of seizure for patient.There were no recent medication changes and the only other change was the vns generator replacement.An assessment on the relation of subclinical seizures to vns therapy could not be provided.An eeg was performed and night time aed dosage was increased as interventions.Patient also started physical therapy for gait issues.Patient outcome was reported to be good as far as physician knew.

Manufacturer Narrative

(b)(4).

• Brand Name: PULSE GEN MODEL 104
• 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: 4617557
• MDR Text Key: 5698447
• Report Number: 1644487-2015-04176
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2016
• Device Model Number: 104
• Device Lot Number: 205203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• 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): Required Intervention
• Patient Age: 18 YR