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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 10/03/2013
Event Type  Injury  
Event Description

On (b)(6) 2013 it was reported that the patient was diagnosed with stage 3 skin cancer on (b)(6) 2013. It was reported that the patient would have cancer removal surgery on her mid back on (b)(6) ; however, this surgery has not been concerned. Follow up with the medical assistant found that the patient called the office on (b)(6) 2013 to report that she had stage 3 melanoma cancer from two moles she had. The medical assistant stated that the patient had the vns implanted for much longer than this and that the cancer was not related to the vns. However, she stated that she would need to confirm this information with the physician as she did not have the authority to verify that there was no relationship. Per the medical assistant, the device was checked in 2012 and found to be fine. No other information was provided.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key3515806
Report Number1644487-2013-03730
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/13/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2014
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/13/2013
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: 12/11/2013 Patient Sequence Number: 1
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