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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 04/19/2006
Event Type  Injury  
Event Description

Reporter indicated the vns therapy system caused a patient's bi-polar disorder to act up. Follow up with the physician confirmed the vns did exacerbate the patient's bi-polar disorder and the device was programmed off; however, good faith attempts to obtain information clarifying if the depression, mania, or both aspects of the disease were exacerbated.

 
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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 Key1404928
Report Number1644487-2009-01243
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/27/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2007
Device MODEL Number102
Device LOT Number14007
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/27/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2006
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: 06/18/2009 Patient Sequence Number: 1
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