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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 02/08/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance. The physician indicated that the patient reported an increase in seizures since about twenty days ago. The patient was sent for x-rays. X-rays were sent to manufacturer for review. No lead breaks or sharp bends were identified. The lead pin did not appear to be fully inserted into the generator header; however, due to the quality of the images this could not be determined. Attempts to obtain additional information have been unsuccessful to date. Surgical intervention has not occurred to date.

 
Manufacturer Narrative

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

 
Event Description

Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient also was experiencing an increase in seizures.

 
Manufacturer Narrative

The initial manufacturer report inadvertently did not include all of the available information regarding the event.

 
Event Description

It was reported that the patient underwent generator and lead replacement. It was reported that the generator was replaced prophylactically. The explanted devices have not been received for analysis to date.

 
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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 Key3710038
Report Number1644487-2014-00826
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/28/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/28/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL Number302-20
Device LOT Number2792
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/12/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/09/2010
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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