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MAUDE Adverse Event Report

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CYBERONICS, INC. LEAD MODEL 302   Back to Search Results
Model Number 302-20
Event Date 03/18/2009
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

Patient physiology caused or contributed to the event.

 
Event Description

It was reported that the electrodes of a vns patient's lead had begun to extrude through the skin of her right neck. Follow up with the patient's explanting surgeon revealed that the event was believed to be related to the patient being allergic to the material on the electrode. Though the patient has undergone several lead replacement surgeries due to patient manipulation, the patient's surgeon and treating vns therapy physician indicated that there had been no admissions of manipulation for this recent event.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1461295
MDR Report Key1397148
Event Key1333279
Report Number1644487-2009-01072
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/08/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date02/29/2008
Device MODEL Number302-20
Device LOT Number200330
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received05/08/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

 
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