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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 06/09/2014
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery on (b)(6) 2014 due to battery depletion, the vns patient¿s lead was also replaced due to lead discontinuity (dc dc ¿ 0). The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The generator replacement was reported in manufacturer report # 1644487-2014-01319.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

On (b)(4) 2014, product analysis was completed on the explanted generator. The reported unable to interrogate allegation, was duplicated (not due to eos) in the product analysis laboratory at two orientations. This is addressed in the physicians manual by instructing the user to reposition the wand. Since product labeling addresses these situations and provides instructions to easily remedy the events (wand position) and (system operation), it is not considered a device malfunction. Bench test verified magnet operation. The generator performed according to functional specifications; during the product analysis there were no anomalies found with the pulse generator. Product analysis on the lead was completed on (b)(4) 2014. A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis a large portion of the returned lead assembly appeared to be twisted and compressed; the outer silicone tubing appeared to be abraded open and abraded openings were observed on both of the inner silicone tubes, in the abraded open area of the outer silicone tubing. During the visual analysis the (-) connector pin and (+) connector ring quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. 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, the condition of the returned lead portion 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 portion were performed, during the visual analysis, and no other discontinuities were identified.

Manufacturer Narrative

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

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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3912101
Report Number1644487-2014-01682
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Type of Report Initial,Followup
Report Date 06/09/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2014
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 Number302-20
Device LOT Number1641
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/12/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/10/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial