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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 01/29/2015
Event Type  Malfunction  
Event Description

Additional information was received that the patient underwent generator and lead replacement surgery due to the reported high impedance. The high impedance was still seen prior to surgery. It was reported that the lead was completely fractured in two when it was explanted. The explanting facility will not be returning the explanted generator or lead to the manufacturer for analysis; therefore, no analysis can be performed.

 
Manufacturer Narrative

Evaluation codes; corrected data: the previously submitted mdr inadvertently provided the wrong conclusion code number. Device failure suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that the patient's device was programmed off and the patient underwent brain resection. The patient continued with seizures and depression so the vns was programmed back on; however, device diagnostics resulted in high impedance (dc dc 7). The patient was referred for surgery.

 
Manufacturer Narrative

Device failure 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 Key4555010
Report Number1644487-2015-04003
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2015
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 Date10/31/2005
Device MODEL Number302-20
Device LOT Number009342
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/03/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2003
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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