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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
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.

 
Manufacturer Narrative

 
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.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key4519331
Report Number1644487-2015-03850
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2011
Device MODEL Number302-20
Device LOT Number200931
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/16/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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