MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); Battery Problem (2885)

Patient Problems Headache (1880); Pain (1994); Seizures (2063)

Event Date 01/11/2014

Event Type  malfunction  

Event Description

Additional programming history was received indicating that device settings had been reduced in (b)(6) 2011.A new battery life calculation was performed with the new settings which showed approximately 5.16 years remaining until neos - yes.

Event Description

On (b)(6) 2014, it was reported that x-rays were taken, and the images showed a lead fracture.The patient was experiencing throat pain with no history of trauma.The patient¿s device was programmed off the next day.The patient underwent generator and lead replacement surgery on (b)(6) 2014.The explanting facility will not return the explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.Clinic notes were received indicating that the vns patient went to the emergency room on (b)(6) 2014 due to a breakthrough seizure and headache.Shunt malfunction was ruled out at the emergency room.The patient had her 2nd breakthrough seizure a week prior to her office visit on (b)(6) 2014.Both seizures were not convulsive.The neurologist stated that both seizures were extremely unusual for the patient.The patient had been seizure free since vns implant while using only one medication.The patient did not have any febrile illness or vomiting/diarrhea.The notes indicate that the diagnostic results showed that the battery was at end of service or near end of service.The neurologist stated that the battery was depleted and could not deliver the necessary therapy to prevent the patient¿s seizures.Attempts for additional relevant information have been unsuccessful to date.Review of the available programming and diagnostic history showed normal diagnostic results through 11/11/2010.A battery life calculation using the available programming history showed approximately 3.68 years until eri = yes.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device failure is suspected, but did not cause or contribute to a death.

Event Description

Additional information was received that the patient had lot of scar tissue seen during the lead and generator replacement.It is unknown if the leak break may have been a contributing cause of the scar tissue.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 3828275
• MDR Text Key: 4426084
• Report Number: 1644487-2014-01308
• 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,Followup,Followup
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2011
• Device Model Number: 302-20
• Device Lot Number: 2239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2008
• 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: 21 YR