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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 04/01/2010
Event Type  Injury  
Event Description

It was reported to the mfr that the vns pt has been hospitalized due to worsening depression. It is unk if the increase is above pre-vns baseline level. The relationship between the increase and vns therapy is unk at this time. It was indicated that the pt needs electroconvulsive therapy. Good faith attempts to obtain additional info regarding the reported event have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1678895
Report Number1644487-2010-01115
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2007
Device MODEL Number102
Device LOT Number012704
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/08/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2005
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: 05/07/2010 Patient Sequence Number: 1
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