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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 03/10/2010
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013 indicated that at the age of (b)(6), the patient started experiencing a second type of seizure that was different from the usual ones. They were of an unknown etiology factor, last approximately 1 minute, occurring 2 to 3 per day, and occur when awake. The patient becomes completely unresponsive, loses awareness, eyes are staring. No automatisms, no stiffening posturing, no tongue or cheek bites, no incontinence. Patient has falling secondary to the seizures. The relationship of the new seizures to vns has been unsuccessful to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Previously submitted mdr inadvertently did not provide the correct product information for the suspect device involved in the event.

 
Event Description

Additional information was received stating that the vns patient¿s seizures were milder after device settings were increased and the patient¿s change in seizure pattern is expected for vns responders. The patient¿s device was tested and showed normal device function.

 
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Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4008513
Report Number1644487-2014-02020
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/16/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2010
Device MODEL Number102R
Device LOT Number200746
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/04/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/05/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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