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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 10/06/2011
Event Type  Injury  
Event Description

Attempts for additional information have been unsuccessful to date.

 
Event Description

It was reported that the pt had been experiencing an increase in seizures a couple months after having his generator replaced prophylactically. It was later found that the pt has been experiencing gran mal seizures which the pt has not had before. The pt's mother indicated that the pt has switched neurologists shortly following generator replacement. The pt's previous physician started the pt on depakote some time after generator replacement. Attempts for further information are in progress.

 
Event Description

Additional information was received indicating that the patient was referred to a surgeon for evaluation; however, the vns has not been evaluated to determine proper device function. The patient's "seizure status is better" after being placed on clonopin. It is unknown if the patient's vns settings are at the therapeutic settings programmed prior to replacement. No interventions appear to be scheduled at this time.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058 770
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 Key2301696
Report Number1644487-2011-02471
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup,Followup
Report Date 09/15/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2012
Device MODEL Number103
Device LOT Number2826
Was Device Available For Evaluation? No
Date Manufacturer Received01/26/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2010
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: 10/14/2011 Patient Sequence Number: 1
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