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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 09/01/2009
Event Type  Injury  
Event Description

It was reported via clinic notes dated 10/28/2009 that the patient was hospitalized for 2 days due to a suicide attempt in (b)(6). The patient does have depression but it is not clear if this is a new onset or if the patient has a history of depression prior to vns. The patient was not receiving any treatment for her depression per the neurologist's knowledge. No changes were made to the patient's vns settings and the neurologist referred the patient to a psychiatrist for treatment of her depression. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102R
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2299164
Report Number1644487-2011-02480
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/22/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2009
Device MODEL Number102R
Device LOT Number200637
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/22/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2007
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: 10/18/2011 Patient Sequence Number: 1
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