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U.S. Department of Health and Human Services

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

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CYBERONICS INC PULSE GEN MODEL UNKNOWN GENERATOR Back to Search Results
Event Type  Malfunction  
Event Description

The initial reporter reported that the patient seemed to be desperate, sinking, getting worse; and needed immediate help. As the patient referenced was indicated for depression, the getting worse; likely refers to an increase in depression. It is unknown what the relationship of the increase is to pre-vns baseline levels. No other information was provided.

 
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Brand NamePULSE GEN MODEL UNKNOWN
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 Key3389223
Report Number1644487-2013-03056
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/06/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/06/2013
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

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