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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 01/19/2015
Event Type  Malfunction  
Event Description

It was reported that the vns patient was experiencing neck pain. The patient¿s device was tested and diagnostic results revealed high impedance (impedance value ¿ 7012 ohms). The patient¿s device settings were subsequently decreased. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2015. It was noted that the patient¿s lead appeared to be ¿falling apart¿ at the nerve. The explanted devices have not been returned to date.

 
Event Description

The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the electrode region. Extensive pitting and evidence of electro-etching were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.

 
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 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 Key4516900
Report Number1644487-2015-03835
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2004
Device MODEL Number302-20
Device LOT Number6442
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/13/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/13/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/28/2002
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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