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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 02/01/2014
Event Type  Malfunction  
Event Description

It was reported that the patient¿s vns system was tested and system diagnostics returned low impedance results with <600 ohms. The pulse generator had been implanted on (b)(6) 2011. The patient underwent revision surgery and it was found during the intervention that the lead was fractured in its upper portion and that the lead appeared to be twiddled. The pulse generator was replaced during the intervention. It was reported that the lead could not be replaced due to lack of an adequate implant site on the left vagus nerve above or below the pre-existing lead electrodes and that implant on the right vagus nerve would be considered. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Further information was received indicating that low impedance was discovered in (b)(6) 2014. The explanted generator was not available for return. Manipulation of the device was not suspected. No known further surgical interventions have occurred to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

No replacement generator was implanted during the surgical intervention.

 
Manufacturer Narrative

Describe event or problem; corrected data: the previously submitted mdr inadvertently reported incorrect information, as it stated that a replacement pulse generator had been implanted. No replacement device was implanted during the reported intervention.

 
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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 Key4878237
Report Number1644487-2015-05067
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL Number302-20
Device LOT Number201126
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2009
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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