MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Anxiety (2328); Loss of consciousness (2418)

Event Date 04/23/2015

Event Type  Injury  

Event Description

It was reported that the vns patient had presented increased seizures for 6 weeks.It was reported that the patient had benefited from vns therapy when the duty cycle was increased from 16% to 29%.Night seizures had not occurred since (b)(6) 2015 after the increase in the duty cycle.The night seizures occurred again six weeks earlier and the patient also presented complex partial seizures during the day, after waking up, with anxiety, rapid heartbeat, panting, stiffening of the arms and partial loss of conscience, being able to hear but not to respond.It was also reported that the vns generator was interrogated and the output current was found at 1ma while it had been programmed at 2ma in the last follow up visit, with the rest of the settings unchanged: frequency 25 hz, pulse width 500usec, 21sec on time, 1.1min off-time, magnet output current 2.25ma.The patient¿s device was tested and system diagnostics returned impedance results within normal limits with dcdc 2 and normal mode diagnostics returned dcdc 5.It was reported that the impedance results were the same as in (b)(6) 2015.It was reported that the output current was set to 2ma and the duty cycle was increased from 29% to 36% with 21sec on-time and 0.8min off-time.The patient had not noticed when vns stimulation did not alter the voice any longer.The patient is (b)(6) years old and has had epilepsy since her (b)(6) year.During the first year she had several seizures per year over a period of 3-4 weeks with anxiety seizures and milder seizures with rapid onset of abdominal pain with paleness without loss of consciousness and generalized tonic-clonic seizures.From her (b)(6) year she presented mainly 3 night seizures per week w, no longer in clusters.The epilepsy is mri negative, with both temporal as frontal symptoms.Review of the available programming and diagnostic history showed normal diagnostic results and no programming anomalies through (b)(6) 2015.Review of manufacturing records confirmed that the generator and the lead passed all functional tests prior to distribution.No known surgical interventions have occurred to date.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that both the generator and the lead passed all functional tests prior to distribution.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 4874298
• MDR Text Key: 5861848
• Report Number: 1644487-2015-05042
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2014
• Device Model Number: 102
• Device Lot Number: 202303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 22 YR