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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 04/26/2011
Event Type  Injury  
Event Description

It was reported through an implant card that a vns patient underwent lead replacement due to fibrosis. At the moment good faith attempts to obtain further information regarding the event with the reporting physician have been unsuccessful to date.

 
Event Description

Additional information was received through the area representative indicating the patient went to the hospital based on symptoms felt. Interventions taken according to the area representative were to disconnect the electrode and then remove it at the time of replacement. A second lead was implanted on the right vagus nerve in order to continue therapy. The explanted lead will not be returned to the manufacturer for analysis. Moreover, information from the treating physician indicated the cause of the fibrosis was likely due to the presence of the device.

 
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2418601
Report Number1644487-2012-00138
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number302-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/28/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/17/2012 Patient Sequence Number: 1
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