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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 11/01/2014
Event Type  Injury  
Event Description

It was reported that the vns patient had been experiencing nocturnal seizures for the past two weeks. The patient stated that the seizures were convulsions and did not cause her to lose awareness. The patient also reported experiencing a change in seizure pattern; she stated she began having other feelings ¿inside¿ along with automatisms. It was noted that the magnet mode stimulation had been helpful in aborting the patient¿s seizures. The patient was instructed to activate magnet mode stimulation a few times before bedtime or during the day. The patient denied any life stressors but believed her ipad may have been triggering her seizures. The patient was instructed to visit with the following physician. Attempts for additional relevant information will be made.

 
Event Description

Additional information was received stating that the vns patient had been experiencing an increase in seizures and a new seizure type in november and (b)(6) of 2014. The seizures were attributed to stress during the holiday season. The patient was seen on (b)(6) 2015 and was doing well. The seizures had resolved and the patient¿s device was functioning well. There was no mention of potential issues with her ipad during the office visit and no further information was obtained as the patient was doing well.

 
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Brand NamePULSE GEN MODEL 103
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 Key4377912
Report Number1644487-2015-03511
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 12/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2013
Device MODEL Number103
Device LOT Number3222
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/26/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/19/2011
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: 01/02/2015 Patient Sequence Number: 1
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