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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 01/27/2015
Event Type  Malfunction  
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
Event Description

Further follow-up revealed that at the patient's visit on (b)(6) 2015 the physician indicated that the patient's medication dosages were to be adjusted due to the adverse events. The patient's mother was reluctant to have medication changes made at that time.

 
Event Description

It was reported on that the vns patient was experiencing an increase in seizures and that magnet mode stimulation was no longer effective in aborting seizures. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. A battery life calculation using the available programming history showed approximately 6. 7 years remaining. Attempts for additional relevant information have been unsuccessful to date.

 
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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 Key4532538
Report Number1644487-2015-03929
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 01/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date06/30/2011
Device MODEL Number102
Device LOT Number201269
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/17/2009
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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