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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 12/30/2014
Event Type  Malfunction  
Event Description

It was reported that, during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement generator was tested with the existing lead and system diagnostic results showed high impedance. The patient underwent lead replacement surgery on (b)(6) 2015. No x-rays were taken. The physician attributed the high impedance condition to the age of the lead. The explanted products have not been returned to date.

 
Event Description

The patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance. The explanted devices from (b)(6) 2015 were returned to the manufacturer for analysis.

 
Manufacturer Narrative

Describe event or problem; corrected date: the previously submitted mdrs inadvertently did not provide the correct type of surgery that occurred. All products were implanted/explanted. There were no products that were opened but not used.

 
Manufacturer Narrative

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

 
Event Description

The opened but unused generator and explanted lead were returned to the manufacturer for analysis. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is currently underway.

 
Event Description

Analysis of the returned lead was completed which confirmed discontinuity of negative quadfilar coil in the electrode region and positive coil in the body region. One strand of the positive coil show that pitting or electro- etching conditions have occurred at the break location.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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 Key4444903
Report Number1644487-2015-03689
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 12/30/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/23/2015
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? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/27/2015
Was Device Evaluated By Manufacturer? Yes
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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