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

Model Number 104

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Seizures (2063)

Event Date 03/13/2015

Event Type  Injury  

Event Description

It was reported that the patient experienced pain is in chest area with vns stimulation after vns dosing appointment on (b)(6) 2015.Device was interrogated and diagnostics ran in multiple positions: sitting, arm raised, arm extended.It is unknown if the pain is related to stimulation as there is minimal time between stimulation period (patient';s settings are 21 sec on and 0.5 min off).The physician did not want to turn off vns due to patient';s worsening of seizure frequency.The increase in seizures is being correlated to the chest pain.The physician lowered output current to 2.5ma and pulse width to 250 usec.Chest and neck x-rays were ordered and patient was started on new medication.The patient's generator was subsequently checked again on (b)(6) 2015 at the surgical consult.Diagnostics were run on patient in 4 different positions and lead impedance came back ok every time.After reviewing x-rays, the surgeon attributed her pain to just normal pain and discomfort from the replacement surgery.No interventions were planned and patient was told to contact surgeon if there is an increase in pain.No further information was received regarding the patient¿s increase in seizures.

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: 4819553
• MDR Text Key: 5903871
• Report Number: 1644487-2015-04843
• 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: Other
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2016
• Device Model Number: 104
• Device Lot Number: 203228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• 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 Age: 25 YR