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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 03/17/2015
Event Type  Injury  
Event Description

Clinic notes were received indicating that the vns patient had been experiencing an increase in seizure duration and seizure frequency which was noted to be at or below pre-vns baseline levels. The patient¿s device was reportedly at end of service. A battery life calculation using the available programming history showed approximately 0. 5 years remaining. The patient underwent generator replacement surgery on (b)(6) 2015. The explanted generator was returned to the manufacturer for analysis. The as-received generator showed an ifi=yes condition. The battery did not display a near end of service or end of service condition during product analysis. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Attempts for additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key4872720
Report Number1644487-2015-05038
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2013
Device MODEL Number104
Device LOT Number3207
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/27/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/13/2011
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: 06/26/2015 Patient Sequence Number: 1
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