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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 05/17/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, clinic notes from a vns treating physician were received. Review of the clinic notes dated (b)(6) 2012, revealed that the patient's seizures seem to be more severe. The patient was reported to have been in a "slump" since last visit and not doing as well. The patient's nightly events are slightly worse and the patient is not improving as much. The physician increased the patient's settings but still no better. The patient was reported to not have any daytime seizures but has nightly nocturnal seizures, not as severe at times. Clinic notes dated (b)(6) 2012, were also received which indicate that the patient's seizures are less severe and no change in frequency. The patient's seizures were reported to have improved with vns changes. The patient stated that nocturnal events occur nightly but not as severe. The patient's vns was adjusted to output=2. 25ma/frequency=20hz/pulse width=250usec/on time=60sec/off time=0. 8min/magnet output=2. 5ma/magnet on time=60sec/magnet pulse width=500usec. Attempts for additional information have been made but no further information has been received from the physician. Although surgery is likely, it has not occurred to date.

 
Event Description

Additional information was received on (b)(6) 2012, when the physician reported that the change in seizure pattern, increase in seizures, and voice alteration were "not an issue". As an intervention the physician adjusted the vns settings and vimpat dosing. The increase in seizures was below pre-vns levels. The voice alteration was associated with stimulation but was not a continual issue.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2646007
Report Number1644487-2012-01719
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2010
Device MODEL Number103
Device LOT Number200807
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/23/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/28/2008
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: 07/09/2012 Patient Sequence Number: 1
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