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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

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CYBERONICS INC BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 01/06/2015
Event Type  Malfunction  
Event Description

An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. Attempts for additional relevant information have been unsuccessful 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 NameBIPOL LEAD MODEL 300
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 Key4532068
Report Number1644487-2015-03919
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/26/2015
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 Date04/30/2000
Device MODEL Number300-20
Device LOT Number9623C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/26/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/07/1998
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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