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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 01/19/2015
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. 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, the lead connector pin, and large portions of the lead could not be assessed due to the poor quality of the images provided. 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. No known surgical interventions have occurred to date.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned 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.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4516985
Report Number1644487-2015-03837
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number302-20
Device LOT Number1937
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2007
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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