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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 11/14/2012
Event Type  Malfunction  
Event Description

An analysis was performed on the returned lead portions and lead break was confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 381mm and 25mm portions the outer / inner silicone tubes appeared to be abraded open / torn. During the visual analysis of the returned 381mm portion the ends of the connector pin and connector ring quadfilar coils appeared to be broken in the area of the abraded open / torn outer / inner silicone tubes. During the visual analysis of the returned 25mm portion quadfilar coil 1 and quadfilar coil 2 appeared to be broken in the area of the abraded open / torn outer / inner silicone tubes. Visual analysis was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the marked 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 other discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

Device malfunction occurred but did not cause or contribute to a death or serious injury.

 
Event Description

A vns patient was referred for a battery change and when a new battery was used, high impedance was discovered. The surgeon noted that during electrode removal he found the lead was completely severed. Due to scar tissue and placement of electrode, a new lead was implanted on the right side. Their explanted lead has been returned for analysis. Completion is pending.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD MODEL 302
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2870688
Report Number1644487-2012-03310
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number302-20
Device LOT Number010939
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/08/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/14/2004
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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