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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 11/16/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was referred for surgery due to high impedance. No known surgical interventions have occurred to date.

 
Event Description

Clinic notes were received indicating that the vns patient had been experiencing an increase in seizures for the past two months. The patient was having one or more gtc seizures per day along with frequent absence seizures. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2015. Lead impedance with the replacement generator and existing lead was within normal limits. 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.

 
Manufacturer Narrative

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

 
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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 Key4399220
Report Number1644487-2015-03574
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 12/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2008
Device MODEL Number302-20
Device LOT Number1300
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/20/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/08/2015 Patient Sequence Number: 1
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