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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 10/15/2013
Event Type  Malfunction  
Event Description

It was reported that the patient would have vns replacement surgery on (b)(6) 2013; however, follow-up information was received which indicated that vns was not implanted on this date. At the time of surgery, it was believed that the electrodes were not on the vagus nerve. The nerve was "disintegrated" and the surgeon had no assessment of what caused the event. No interventions were taken or planned. The generator and lead were explanted and discarded. The patient was not implanted with another vns device. It was unknown if this event was related to vns. No other information was provided.

 
Event Description

On (b)(6) 2013 it was reported that the patient was found to have high lead impedance during an office visit on (b)(6) 2013. The physician requested x-rays and the device was not disabled. The physician sated that the only trauma was that the patient recently had a mammogram which was a little rough but he did not think it would have caused any issues with the device. Clinic notes were received from the (b)(6) 2013 visit which indicated that the diagnostics test showed high lead impedance with a dcdc of 7. The physician indicated that the high impedance may be related to some scar tissue. The patient reported no seizure since her previous appointment in (b)(6) 2013. The patient was referred for surgery. A copy of the patient¿s x-rays were received for review. Due to image angle and quality, complete lead pin insertion cannot be assessed. The lead portion behind the generator cannot be assessed. There are no sharp angles in the lead; however, there is a suspect area of continuity in the lead portion in the chest. The assessment of community in this area is limited by image quality. Based on the images available, the suspect area of continuity in the lead may be a cause for the high impedance. The presence of a microfracture or a discontinuity in the lead portion not visible cannot be ruled out. Although surgery is likely, it has not occurred to date. Review of the lead device history records confirmed all quality tests were passed prior to distribution.

 
Manufacturer Narrative

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 Key3484513
Report Number1644487-2013-03574
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/22/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2011
Device MODEL Number302-20
Device LOT Number200754
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/16/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/10/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/22/2013 Patient Sequence Number: 1
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