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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101

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CYBERONICS, INC. PULSE GEN MODEL 101 Back to Search Results
Model Number 101
Event Date 09/01/2010
Event Type  Injury  
Event Description

It was initially reported in clinic notes that the patient had an increase in seizures (b)(6) 2010, unknown if above or below pre-vns baseline. Emergency medical technician were called for one seizure when the patient did not respond to sternal rub. The patient blood sugar was low (60) and the physician suspected that low blood sugar was the cause of the seizures but was not completely sure that was the cause. There were no medication changes preceding the increase in seizures. Good faith attempts for more information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2193840
Report Number1644487-2011-01758
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/06/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2002
Device MODEL Number101
Device LOT Number1596
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/06/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2000
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: 08/02/2011 Patient Sequence Number: 1
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