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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 10/02/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, it was reported that the patient had a full vns replacement due to the battery being at end of service and because the lead "didn't work either". Follow up with the physician found that the patient had the lead replaced due to high lead impedance observed during surgery. When the patient as opened up, it was found that the electrodes were originally placed on another nerve and not the vagus nerve. Instead, the electrodes were placed on the ansa cervicalis nerve, which is about one third of the size of the vagus nerve, per the surgeon. This led to the patient developing scarring around the nerve and electrodes, which is what the physician believes is the cause of the high impedance. However, as the patient reported some benefit from vns, the physician believes that some stimulation was being delivered. The lead appeared intact, per the physician, so the high impedance was attributed to the scarring. Review of the lead device history records confirmed all quality tests were passed prior to distribution. The explanted device was returned to the manufacturer and product analysis was performed. Product analysis of the lead found no product related anomalies. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Attempts were made for additional information; however, no additional information was provided.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, 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 Key3443385
Report Number1644487-2013-03367
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/03/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/01/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2009
Device MODEL Number302-20
Device LOT Number1609
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/10/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/03/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/06/2006
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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