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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 10/15/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device showed a high impedance condition (impedance value >= 10,000 ohms). Diagnostic results for the past year showed normal device function. X-rays were taken and reported to show the lead being ¿angulated. ¿ x-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Additional information was received stating that the vns patient¿s device first showed a high impedance condition during an office visit on (b)(6) 2015. The patient¿s device was subsequently disabled.

 
Event Description

It was reported the patient was re-implanted with a new vns on (b)(6) 2016; however, this was later confirmed invalid by the physician who noted the patient was re-implanted on (b)(6) 2016. The surgery was a full revision and the patient received a new lead and vns generator. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The explanted lead and generator were received by the manufacturer for analysis. The lead analysis was completed and a lead break was confirmed as a coil break was identified on what was believed to be the negative coil. Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break locations. Due to pitting, mechanical distortion (smoothed surfaces), and/or surface contamination, the fracture mechanism of the coil could not be ascertained. Generator analysis is expected but has not been completed to date.

 
Event Description

Product analysis for the returned generator was completed. The review of the ram/flash data downloaded from the generator shows an indication of increased impedance from 5267 ohms to 10,013 ohms, and the date of change detection of (b)(6) 2014 (explant date (b)(6) 2016). The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2013 with an impedance value of 2133 ohms (implant date (b)(6) 2012). Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications. The batter voltage indicated an ifi = no condition. There were no performance or any other type of adverse conditions found with the 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 Key4554478
Report Number1644487-2015-04002
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number302-20
Device LOT Number945
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/06/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2005
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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