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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 01/28/2015
Event Type  Malfunction  
Event Description

The explanted generator was returned for analysis on 03/02/2015. Product analysis for the m102 generator was completed and approved on 03/19/2015. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

 
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 diagnostic results showed high impedance. The lead pin was reinserted into the generator header but the high impedance condition did not resolve. The replacement generator was tested with a test resistor and generator diagnostic results showed normal device function. The lead was replaced during the procedure. The explanted devices have not been returned to date. It was noted that the lead was ¿scarred¿ around the generator.

 
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 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 Key4535482
Report Number1644487-2015-03938
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2010
Device MODEL Number302-20
Device LOT Number200489
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/24/2007
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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