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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105

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CYBERONICS INC PULSE GEN MODEL 105 Back to Search Results
Model Number 105
Event Date 02/27/2013
Event Type  Injury  
Event Description

A vns treating physician reported that his patient was seen (b)(6) 2013 and the patient is having seizure clusters now but there is no increase in number of seizures. He also reports that patient recently had her first grand mal seizure. The patient's medications have been stable and the physician was wondering why her seizures have changed to clusters and reason for her first grand mal. The patient was set at 2. 25ma output current and he decreased her output to 1. 25ma (b)(6) 2013. Her off time was adjusted from 0. 3 to 0. 2. Good faith attempts have been made for further details and at this time no further information has been attained.

 
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Brand NamePULSE GEN MODEL 105
Type of DevicePULSE GEN MODEL 105
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key3012670
Report Number1644487-2013-00741
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number105
Device LOT Number202083
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/20/2012
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: 03/20/2013 Patient Sequence Number: 1
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