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

Model Number 302-20

Device Problems High impedance (1291); Unintended Collision (1429)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/15/2013

Event Type  malfunction  

Event Description

Initially, it was reported that the patient had not been feeling stimulation or noticing voice alteration with device stimulation for the past three weeks.It was later reported that high impedance was observed when device diagnostics were run.It was reported that the patient was recently pushed by a patient she cares for.It was reported that the device was programmed off after observing the high impedance.It was reported that arrangements have been made to have x-rays and the patient was referred to surgeon.The patient underwent surgery on (b)(6) 2013.It was reported that pre-operative diagnostics resulted in high impedance (dc dc code - 7).During the surgery, the generator was replaced and diagnostics were within normal limits.It was reported that several positional changes were made and all diagnostics continued to be within normal limits.The patient was closed and the device was programmed on.The generator was received for analysis on (b)(6) 2013.Analysis of the generator was completed on (b)(6) 2013.The generator performed according to functional specifications.During the product analysis, there were no anomalies found with the pulse generator.

Event Description

It was reported that the vns patient was experiencing an increase in seizures above pre-vns baseline levels.It was reported that the device was programmed off following the high impedance observation; however the generator was found to be programmed to an output current of 0.25ma at generator replacement surgery.Additional information was received stating that x-rays were taken and were reported by the physician to be unremarkable.X-rays have not been provided to the manufacturer for further review.The patient was having complex partial seizures with secondary generalization and an increase frequency of partial seizures.No medication changes or external factors that could have caused or contributed to the increased seizures were reported.The neurologist increased the patient¿s medication changes for the increase in seizures.The neurologist stated that patient¿s increase in seizures was possibly related to the observed high impedance.The neurosurgeon stated that the increase in seizures may be due to end of service.No known surgical interventions have occurred to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

The initial manufacturer report inadvertently did not include that the patient was experiencing an increase in seizures and that the device was programmed on.

• 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: 3551838
• MDR Text Key: 4214859
• Report Number: 1644487-2014-00065
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 09/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 01/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2005
• 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: 50 YR