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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (dc dc ¿ 7) and a near end of service condition.No patient adverse events were reported.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Additional information was received by the manufacturer that the patient's generator was explanted on (b)(6) 2014 and replaced due to end of life and will be returned to the manufacturer for analysis.The high lead impedance result was obtained upon diagnostic test performed on the patient's generator on (b)(6) 2014, following device explant from the patient.Confirmation was received from the nurse that the vns patient was seen in clinic on (b)(6) 2014, following generator replacement and the device is still insitu and fully functional.The explanted generator for analysis is expected, but it has not been received to date.

Event Description

Analysis was completed on the generator.An end-of-service warning message was verified in the product analysis and found to be associated with the output being disabled by the pulse generator due to the pulse generator remaining ¿on¿ post explant.Review of the ram/flash data downloaded from the pulse generator shows an indication of post explant increased impedance; the ¿diagvinitialprechange¿ value of 2682 ohms, the ¿diagvinitialpostchange¿ value of 21079 ohms, and the time of change detection (b)(6) 2014 (explant (b)(6) 2014).C4 (v cpu) capacitor out of specification conditions associated with component aging is an issue.A battery life calculation of 0.0 years remaining before the near-end-of-service (neos) flag would be set to a neos=yes condition was found.A review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy (diagmagnetconsumedm).(b)(4).Other than the noted events (consumed, pulse disabled ¿vboost¿, and c4), there were no additional performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 4519331
• MDR Text Key: 5441575
• Report Number: 1644487-2015-03850
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2008
• 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