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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 302-30
Event Date 01/01/2015
Event Type  Injury  
Event Description

Initially it was reported that the patient was scheduled for generator and lead replacement for an unknown reason. It was reported that the generator was replaced due to end of service and that it was believed that the patient experienced an increase in seizures, but the pre-vns baseline frequency is unknown. The patient requested to have the lead replaced due to the lead having become more prominent over the last year and pain in the neck when turning head in different directions for 2 weeks prior to surgery. The reason for the protrusion is unknown. Device diagnostics were within normal limits. It was reported that the lead was replaced to preclude a serious injury and for patient comfort. The pain and protrusion resolved following generator and lead replacement surgery. The explanted lead was discarded during surgery. The explanted generator was returned for analysis on 02/10/2015. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

 
Event Description

Analysis of the generator was completed on 03/05/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

 
Manufacturer Narrative

 
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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 Key4570551
Report Number1644487-2015-04043
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number302-30
Device LOT Number200556
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/05/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/12/2007
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: 03/04/2015 Patient Sequence Number: 1
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