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U.S. Department of Health and Human Services

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

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CYBERONICS INC PULSE GEN MODEL 102 PULSE GEN MDOEL 102 Back to Search Results
Model Number 102
Event Date 09/01/2012
Event Type  Injury  
Event Description

All attempts to the reporter for additional information have been unsuccessful to date.

 
Event Description

Reporter indicated via clinic notes received to the manufacturer that a vns patient was experiencing breakthrough seizures that may be hormonal in nature, as the seizures occurred during the patient's menstrual cycle. The seizures include blackouts. It was unclear if the vns was felt to be a cause, or stress/hormones. Vimpat medication was increased as an intervention, and the vns settings were increased. Treatment with depo-provera is recommended to prevent her hormones from fluctuating and causing seizures per the reporter. Replacement of the vns generator is likely, but is not expected to occur for several months at the patient's preference. Attempts for further information are in progress.

 
Event Description

Reporter indicated the increased seizures (3 seizures) occurred the day after the patient received a depo-provera injection. The level of the seizure increase is unknown, as the patient is new to the office. An increase in vimpat medication preceded the seizure increase, but the patient's seizures now have improved with the increase in vimpat. The patient's seizures fairly well-controlled at this time, with few breakthrough seizures.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MDOEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2780787
Report Number1644487-2012-02574
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/12/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2005
Device MODEL Number102
Device LOT Number009405
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/13/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/20/2003
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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