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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 01/23/2015
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance. The patient was referred for surgery. It was later reported that during the surgery the pre-operative device diagnostics resulted in high impedance (>10,000 ohms). The device was interrogated and found to be programmed on to 2. 25ma. There was an x-ray in the operating room that showed an obvious lead break. The surgeon dissected the electrodes off of the nerve and reimplanted a new generator and lead. Device diagnostics with the generator out of the pocket and in the pocket were both within normal limits. The new generator was left programmed off. It was reported that both the generator and lead were discarded in surgery; therefore no product analysis can be performed.

 
Manufacturer Narrative

Device failure occurred, 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
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 Key4532896
Report Number1644487-2015-03936
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2010
Device MODEL Number302-20
Device LOT Number200419
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2007
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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