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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 01/01/2015
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s device also showed high impedance so the lead was also replaced during the procedure. X-rays had been previously taken which showed a bend in the lead approximately 4cm from the anchor tether. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. The explanted devices have not been returned to date.

 
Event Description

The explanted lead and generator were received on (b)(6) 2015 and they are currently undergoing analysis.

 
Event Description

Analysis of the lead was completed on (b)(4) 2015 and it identified a break in the negative coil, 2mm from the proximal end of the anchor tether. Evidence of a stress-induced fracture was found at the break area, with mechanical damage and pitting. During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (-) white electrode ribbon from coming in contact with the vagus nerve. No other discontinuities were identified. The positive electrode ribbon presented remnants of dried body tissue. Findings consistent with an explant procedure were also identified. Analysis of the returned generator was completed on (b)(4) 2015. The battery voltage was 2. 975 volts, which indicates an ifi=no condition. No adverse conditions were found on the generator. The generator performed according to specifications.

 
Manufacturer Narrative

Review of the available programming and diagnostic history. 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.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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 Key4528383
Report Number1644487-2015-03898
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/22/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2011
Device MODEL Number302-20
Device LOT Number200931
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/23/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/27/2008
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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