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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 11/07/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2013 additional information was received indicating that the event began (b)(6) 2012. The patient has problematic behavior with hyperkinetic and aggressive way of acting, so trauma cannot be excluded. Surgery is likely but has not taken place.

 
Event Description

X-rays were received and reviewed by the manufacturer. No acute angles were observed in the assessed portions of the lead, but one break was found next to the second tie-down. Based on the x-ray images, the reason for the reported high lead impedance is likely the lead break identified.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted devicereview of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Date of event, corrected data: previously submitted mdr stated the incorrect event date: additional information was received showing that event date is (b)(6) 2012. This report is being submitted to correct this information.

 
Event Description

Reporter indicated high lead impedance was noted for a patient with vns diagnostics testing at an office visit. The generator was disabled. X-rays were ordered. The patient no longer has voice alteration with stimulation since approximately two weeks before the high lead impedance was noted. Attempts for additional information are in progress.

 
Manufacturer Narrative

Device failure is suspected, but did not cause a death or serious injury.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2879594
Report Number1644487-2012-03390
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/22/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2010
Device MODEL Number302-20
Device LOT Number1925
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/04/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/25/2007
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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