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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 02/27/2015
Event Type  Malfunction  
Event Description

During a generator replacement on (b)(6) 2015 due to battery depletion, the surgeon identified the lead insulation on the electrode to be somewhat discontinuous within the generator pocket. Multiple areas of the electrode lead insulation were discontinuous with exposed wire. The surgeon therefore decided to replace the lead along with the generator. The explanted generator and lead were received by manufacturer on 3/12/2015. Analysis is underway but has not been completed.

 
Event Description

The pulse generator diagnostics were as expected for the programmed parameters. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. The lead assembly was returned in four portions with one tie down attached. The electrodes were not returned. Multiple abraded opening were observed on the outer silicone tubing and on the marked and unmarked inner silicone tubing. The outer silicone tubing appeared to be compressed in some areas.

 
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 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 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 Key4635950
Report Number1644487-2015-04246
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2002
Device MODEL Number300-20
Device LOT Number35713C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/12/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2000
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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