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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 03/06/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested and diagnostic results showed high lead impedance (impedance value - 6709 ohms) during an office visit on 03/06/2014. X-rays were taken but have not yet been provided to manufacturer for evaluation. The device was not disabled. The patient is often injured because she has drop attack seizures, which may have caused or contributed to the reported high impedance. However, no definitive conclusions can be made with the available information. Review of the available programming and diagnostic history showed normal diagnostic results through 08/01/2013. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

 
Event Description

Additional information was received indicating that the patient underwent surgery. During the surgery, a new generator was attached to the existing lead and device diagnostics were within normal limits (3767 ohms). It was reported that the patient's head and neck were placed in different positions and subsequent diagnostics were within normal limits. The surgery was finalized with only generator replacement. It was later reported that device diagnostics again resulted in high impedance (>10,000 ohms). The generator was programmed off and the patient was referred for lead replacement. No known surgical intervention have been performed to date. The generator was received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date.

 
Event Description

Additional information was received stating that the vns patient underwent lead replacement surgery on 09/05/2014 due to lead discontinuity. The explanted lead has been returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the generator was completed on 08/07/2014. Results of the analysis will be reported on the quarterly remedial actions exemption report.

 
Event Description

Analysis of the returned lead was completed. During the visual analysis, connector pin and connector ring quadfilar coils appeared to be broken. Pitting was observed on the coil surfaces. Remnants of dried body tissue were observed wrapped around a portion of helical and green electrode ribbon. This condition may have prevented the green electrode ribbon from coming in contact with the vagus nerve. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities and the tissue-covered green electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.

 
Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history 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.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.

 
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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 Key3733255
Report Number1644487-2014-00905
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2012
Device MODEL Number302-20
Device LOT Number2256
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/22/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/15/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/12/2009
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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