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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL UNKNOWN

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CYBERONICS INC LEAD MODEL UNKNOWN Back to Search Results
Event Date 03/14/2014
Event Type  Injury  
Event Description

It was reported that during initial vns implant surgery on (b)(6) 2014, the surgeon observed a large mass in the patient¿s neck overlaying the carotid and nerve making it impossible for the surgeon to even locate carotid. The surgeon subsequently decided to abort the surgery.

 
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Brand NameLEAD MODEL UNKNOWN
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3738583
Report Number1644487-2014-00952
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/14/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/14/2014
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: 04/10/2014 Patient Sequence Number: 1
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