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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 08/01/2004
Event Type  Injury  
Event Description

Additional information was received regarding the patient. The cause of the increase in seizures is unclear at this time. Based on the family report the patient only had grand mal seizures pre-vns. The family feels that the frequency and intensity has gotten worse, but the history of the patient's seizures has not been well documented.

 
Event Description

Additional information was received that indicated that the patient felt that the seizures may be related to stress and anxiety. The off time was adjusted from 5 minutes off to 3 minutes off.

 
Event Description

It was initially reported that the patient was having an increase in seizure frequency and more intense seizures which were above pre-vns baseline. The patient's seizures improved and were well controlled for about two years post implant but since that time they have become worse. The patient's device was reported to be "ok" by the physician but he is concerned about her condition so prescribed her more medications. Good faith attempts for more information have been unsuccessful to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 101
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2250673
Report Number1644487-2011-02184
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 08/25/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2003
Device MODEL Number101
Device LOT Number6288
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/05/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/10/2002
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: 09/16/2011 Patient Sequence Number: 1
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