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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/01/2011
Event Type  Injury  
Event Description

It was initially reported that the patient was experiencing an increase in seizures, unknown if above or below baseline. The seizures are reported to be mild in severity but occurring frequently. The patient is schedule for generator replacement which has not occurred to date. Good faith attempts for more information have been unsuccessful to date.

 
Event Description

Additional information was received indicating that the patient had a generator replacement. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.

 
Event Description

Additional information was received that indicated that product analysis was completed on the generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 102
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 Key2270842
Report Number1644487-2011-02325
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/09/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2005
Device MODEL Number102
Device LOT Number8625
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/01/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/16/2003
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: 09/30/2011 Patient Sequence Number: 1
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