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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 09/23/2013
Event Type  Injury  
Manufacturer Narrative

Evaluation codes-conclusions, corrected data: based on the initial report, there is no allegation of a device failure as the adverse event is believed to be related to medication changes. This report is being submitted to correct this information.

 
Event Description

On (b)(6), 2013, the patient reported that she saw the physician around (b)(6). The patient stated that the physician doubled her keppra dosage and left the vns settings the same. Following the change in medication, the patient experienced an increase in seizures and began having a new seizure type. The patient had two mini grand mal seizures and one grand mal seizure. The patient attributes the increase in seizures to the medication changes, but did not specifically comment on the relationship of the new seizure type to the medication changes or vns. No other information has been provided.

 
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Brand NamePULSE GEN MODEL 103
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 Key3528909
Report Number1644487-2013-03857
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 11/22/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL Number103
Device LOT Number3449
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2012
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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