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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 03/24/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (impedance value ¿ 9737 ohms). The patient recently underwent generator replacement surgery on (b)(6) 2014 and the impedance value prior to and following generator replacement surgery reportedly showed lead impedance within normal limits. X-rays were provided to the manufacturer for further review. The generator is seen in the left chest. With the images provided, it appears that the connector pin is not fully inserted inside the connector block. The filter feedthru wires appear to be intact. The lead wire appears to be intact at the location of the connector pins. There is a portion of the lead located behind the generator that could not be assessed. The lead is routed upwards to the left side of the neck, and the electrodes appear to be alignment. There do not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized; however, the presence of a fracture cannot be ruled out due to the quality of the images. No known interventions have occurred to date.

 
Event Description

Additional information was received indicating that the vns patient's device was programmed off following the high impedance observation. Diagnostic tests were not performed after generator replacement surgery and prior to the high impedance observation. The physician stated that trauma possibly caused or contributed to the reported high impedance. Further follow-up revealed that during generator replacement surgery, the surgeon had to remove fibrous tissue from both electrodes. The replacement generator was tested with the existing lead and diagnostic results revealed good connection. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

X-rays reviewed by manufacturer, lead pin not fully inserted past the connector block of generator.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury. Additional information indicates that the suspect device is the lead. Additional information indicates that the operator of the device was the patient. Additional information indicates that user error did not cause event.

 
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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 Key3797363
Report Number1644487-2014-01213
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 04/13/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/07/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2010
Device MODEL Number302-20
Device LOT Number200673
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/05/2007
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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