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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 01/27/2015
Event Type  Malfunction  
Event Description

It was reported that during prophylactic generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement generator was tested with the existing lead and system diagnostic results revealed high impedance (impedance value ¿ 5964 ohms). The lead pin was reinserted into the generator header multiple times but the high impedance condition did not resolve (impedance value ¿ 6683 and 7091 ohms). Generator diagnostics for the replacement generator showed normal device function. The old generator was tested with the existing lead and system diagnostics showed high impedance (dcdc ¿ 7). Preoperative diagnostic results with the old generator showed lead impedance within normal limits (dcdc ¿ 1). The lead was also replaced during the procedure. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

 
Manufacturer Narrative

Device failure is suspected, 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 Key4532362
Report Number1644487-2015-03925
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/27/2015
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 Date10/31/2005
Device MODEL Number302-20
Device LOT Number009405
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2003
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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