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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 11/09/2010
Event Type  Injury  
Event Description

It was reported that the patient was implanted on (b)(6), 2010, after which she fell into a status of epilepticus with complex partial seizure (stimulation not turned on at that time), which she had not experienced before. Due to this condition, the patient has been in an intensive care unit and has received aed on high dose since (b)(6), 2010. The patient stabilized, but remained in the icu as of (b)(6), 2010, and the stimulation has been turned on. Attempts for further information 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 Key1936649
Report Number1644487-2010-02845
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 11/17/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number102
Device LOT Number2379
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received11/17/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2009
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: 12/17/2010 Patient Sequence Number: 1
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