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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 302-30
Event Date 03/06/2012
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in a high impedance reading. The patient was sent for x-rays and the radiologist's report indicates that the lead pins did not appear to be fully inserted into the generator header. The device was programmed off per manufacturer's recommendations. It was reported that the patient's family has declined surgical intervention because they feel the patient has not received much benefit from vns therapy. Review of the device programming history identified that the patient had high impedance at implant which was resolved on the day of implant. The high impedance was later found on diagnostics on (b)(6) 2012.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Analysis of programming history. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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
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 Key3406576
Report Number1644487-2013-03157
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/13/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2006
Device MODEL Number302-30
Device LOT Number011454
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/13/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2004
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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