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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

Additional information was received via an implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high lead impedance. The neurologist reported that he does not know what may have cause the high impedance as no trauma or manipulation had occurred. The high impedance was confirmed on system diagnostics prior to the surgery. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

 
Event Description

Clinic notes were received indicating that the vns patient¿s device showed high impedance on (b)(6) 2015. The patient was referred for surgery but no known surgical interventions have occurred 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 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 Key4553601
Report Number1644487-2015-03773
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2008
Device MODEL Number302-20
Device LOT Number1391
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 Manufactured11/09/2005
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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