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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 302-30
Event Date 07/21/2014
Event Type  Malfunction  
Event Description

On (b)(6) 2014 it was reported that during the patient¿s prophylactic battery replacement surgery, the surgeon noticed that the lead had some kind of abrasion allowing fluid to leak in. Diagnostics were noted to be good. The patient underwent lead revision as well due to the fluid leak. The explanted generator and lead were received for product analysis on (b)(6) 2014. Product analysis is still underway and has not yet been completed.

 
Manufacturer Narrative

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 a death or serious injury.

 
Event Description

On (b)(4) 2014 product analysis was completed on the lead. Several outer tubing abraded openings were observed; except for the abraded openings in the outer tubing, there were no other observed product related issues with the returned lead portions; appears that neither electrical functionality nor electrical current path flow were adversely impacted. Portions of the (+) white and (-) green inner silicone tubes and quadfilar coils including the anchor tether and (+) white electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis several abraded openings were observed on the outer silicone tubing. The lead assembly had dried remnants of what appear to have once been body fluids inside outer and inner silicone tubes, in some areas. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Product analysis on the generator was also completed. Analysis in the pa lab found that the elective replacement indicator (eri) flag was set; an open can measurement of the battery voltage confirmed that the eri flag had been properly set. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to a "partially depleted" battery condition. A battery life calculation resulted in 0. 28 years remaining before the eri flag would be set. However, an incomplete programming history indicates the calculation does not use all the data required to make an accurate estimation. The device performed according to functional specifications.

 
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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 Key4007976
Report Number1644487-2014-02019
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2009
Device MODEL Number302-30
Device LOT Number200241
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/26/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/23/2006
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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