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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 06/28/2011
Event Type  Malfunction  
Event Description

The patient had full revision surgery on (b)(6) 2013, and their explanted products have at this time not been returned for analysis.

 
Event Description

The explanted generator and lead will not be returned for analysis.

 
Event Description

It was reported that the patient's vns is indicating high lead impedance. The physician believes the vns may have been damaged during cardiac surgery for valve replacement and aneurysm repair on (b)(6) 2011. However, the vns had not been checked since (b)(6) 2011. Both of the cardiac events are reportedly not related to vns therapy. Attempts for additional information have been unsuccessful to date. Surgery to replace the vns lead and generator is likely. No adverse events have been reported.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received indicating no x-rays were taken to evaluate for a lead fracture. The physician confirmed that the high impedance is believed to be a result of damage incurred during open heart surgery. The patient has had increased seizures since the time of the surgery that was originally believed to be related to the surgery however the increased seizures did not resolve after some time leading to the physician suspecting an issue. The seizures were noted as slightly improved following surgery and the overall increased seizure frequency was noted as being below the pre-vns baseline. The physician disabled the patient's vns when the high impedance was discovered on (b)(6) 2012.

 
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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 Key2650301
Report Number1644487-2012-01739
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/11/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/01/2008
Device MODEL Number302-20
Device LOT Number954
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/19/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/24/2005
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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