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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 06/01/2011
Event Type  Injury  
Event Description

It was reported that the pt incision on his neck had opened due to his helmet strap rubbing on it and the lead was visible through the opening. The pt had surgery to close the incision.

 
Event Description

Additional information was received that the patient had another surgery due to the lead extrusion. The surgeon opened the incision site and positioned the lead so that it was no longer extruding from the neck. The surgeon will explant the patient if this occurs again. The surgeon still believes this is due to the patient's helmet rubbing against the neck. There was no infection present and diagnostics before and after the procedure with within normal limits.

 
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Brand NameLEAD MODEL 303
Manufacturer (Section D)
CYBERONICS, INC.
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 Key2180950
Report Number1644487-2011-01666
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2009
Device MODEL Number303-20
Device LOT Number200304
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received11/30/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/14/2006
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: 07/22/2011 Patient Sequence Number: 1
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