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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 02/11/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was experiencing an increase in seizures on (b)(6) 2014. The patient was re-implanted with a new generator on (b)(6) 2014 and did not have any seizures since the surgery until the day after the device was programmed on during an office visit on (b)(6) 2014. Attempts for additional information have been unsuccessful.

 
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Brand NamePULSE GEN MODEL 102
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 Key3677819
Report Number1644487-2014-00684
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/13/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2015
Device MODEL Number102
Device LOT Number3682
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/13/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/19/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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