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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 01/01/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013 note that the patient has a new type of seizure this year where his legs go out from under him and he will just fall backwards and convulse. The relationship of the new type of seizure to vns is unknown. Attempt to obtain additional information have been unsuccessful to date.

 
Event Description

The generator was returned for analysis on (b)(4) 2013. The returned product form indicated that the generator was explanted on (b)(6) 2013 due to prophylactic replacement. Attempts to obtain additional information have been unsuccessful to date. Analysis of the generator was completed on (b)(4) 2013. In the pa 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3397235
Report Number1644487-2013-03092
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number102
Device LOT Number015950
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/19/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/19/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/28/2006
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: 10/09/2013 Patient Sequence Number: 1
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