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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 01/05/2015
Event Type  Malfunction  
Event Description

Analysis of the explanted generator was completed. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the explanted lead was completed. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil broken ends and strand fragments show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, mechanical distortion (smoothed surfaces), and /or surface contamination the fracture mechanism cannot be ascertained. Abraded openings of both the outer and inner silicone tubing were also observed near the break location with dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received that the patient underwent generator and lead replacement surgery due to prophylactic generator replacement and lead discontinuity. System diagnostics following revision showed normal results without high impedance. The generator and lead were received for product analysis. Analysis is currently underway but has not been completed to date.

 
Event Description

It was reported that the vns patient¿s device showed low output current delivered and high lead impedance. The device was disabled and the patient was sent for x-rays. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a 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 Key4460830
Report Number1644487-2015-03704
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/05/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/16/2004
Device MODEL Number302-20
Device LOT Number7036
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/04/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/24/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/18/2002
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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