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

Model Number 102

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

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271); Neck Pain (2433)

Event Date 10/06/2014

Event Type  Injury  

Event Description

Clinic notes were received indicating that the vns patient believed something was wrong with her lead during an office visit on (b)(6) 2014.The patient was experiencing neck pain, so the physician subsequently lowered the patient¿s device settings.During an office visit on (b)(6) 2014, the patient¿s device was tested and diagnostic results showed normal device function.The patient had a seizure in the office in which she was unresponsive and leaning her head back and forth with her eyes closed.No shaking or rhythmic movement was noted.The magnet was used and the seizure lasted approximately three minutes.The patient opened her eyes but was unresponsive for several minutes.The patient was unaware of the seizure.Since her last office visit on (b)(6) 2014, the patient had eight gtc seizures and had been to the er twice.The physician was questioning the battery status of the patient¿s device.A battery life calculation using the available programming history showed approximately three years remaining until neos = yes.The patient underwent generator replacement surgery on (b)(6) 2014.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description

Additional information was received stating that the vns patient¿s increase in seizures was due to the decrease in device settings.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4377886
• MDR Text Key: 5266665
• Report Number: 1644487-2015-03513
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: 102
• Device Lot Number: 201423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2010
• 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: 41 YR