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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 the vns patient¿s device showed high impedance. The patient had been experiencing an increase in seizures for the past few weeks. The patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.

 
Event Description

The explanted lead was received by the manufacturer on 02/23/2015 and is currently undergoing analysis.

 
Event Description

Analysis of the lead was completed on 03/16/2015 and it identified a break in the positive coil with pitching and electro-etching at the break location. The appearance of one strand of the positive coil broken end suggest that the fracture could be induced by stress, but it cannot be confirmed due to mechanical distortion, pitting and surface contamination. Additionally, abraded openings of the outer and inner silicone tubing were identified. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
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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 Key4519312
Report Number1644487-2015-03849
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 01/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2010
Device MODEL Number302-20
Device LOT Number200441
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 Received03/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/16/2015 Patient Sequence Number: 1
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