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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 03/15/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2014 note that since the patient's last visit on (b)(6) 2013, the patient has experienced an increase in seizures. It was noted that the patient's lamictal was increased and the patient's seizures improved. It was noted that the patient suffered a second increase in seizures in september 2013. It was noted that the lamictal was increased a second time; however, little improvement was seen. It was noted that the patient's seizures went from one seizure a month to 4-5 seizures a month. It was noted that the seizures tend to occur two weeks prior to her menses and either the week of or the week after her menses. The seizures often occur in pairs; she has a seizure in the evening around dinner time and one the following morning several hours after awakening. The notes indicate that the patient's seizures have changed in character since (b)(6) 2013. It was noted that the patient now becomes still and "falls like a tree, often on her face". It was noted that in the past her habitual seizures were described as staring and lip smacking. Initially, the increase and change in seizures was reported on mfr. Report # 1644487-2014-01499 as the increase and change in seizures were thought to be related to the high impedance event in this report. Information received on (b)(6) 2014 indicates that the increase and change in seizures occurred prior to the high impedance event. It is unknown if the increase in seizures is above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3963844
Report Number1644487-2014-01879
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/01/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2014
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 Number202091
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/01/2014
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: 07/29/2014 Patient Sequence Number: 1
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