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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 11/07/2011
Event Type  Injury  
Event Description

On (b)(4) 2011, the manufacturer's consultant reported that during the patient's implant surgery on (b)(6) 2011, the vns implanting surgeon somehow nicked or tore the patient's jugular or carotid artery. The surgeon had noticed some scarring from the patient's previous implant around the vagus nerve and while the surgeon was cleaning up the scar tissue around the vagus nerve either he nicked the artery or the scar tissue was attached to the artery and tore some tissue from it. The surgeon was able to repair the artery this during the surgery and the patient was implanted as intended. The diagnostics were all within normal limits and no other problems were encountered during the implant. The surgeon later clarified that it was the carotid artery where the damage occurred and it was torn from scar tissue removal.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key2352130
Report Number1644487-2011-02881
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2015
Device MODEL Number304-20
Device LOT Number201887
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/07/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/28/2011
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: 11/29/2011 Patient Sequence Number: 1
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