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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 103 GENERATOR

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CYBERONICS PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 07/01/2014
Event Type  Injury  
Event Description

It was reported that the vns patient presented an increased number of seizures for the past six months. Aed were added for treatment. Vns parameters were increased. There were no changes to medication or vns settings or other external factors that preceded the onset of the increase in seizures. The generator battery appeared to be nearing end of service which was believed to be the cause of the patient¿s increase in seizures. It was noted that the patient¿s magnet was not aborting the patient¿s seizures. The patient¿s device was tested and system diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key4472980
Report Number1644487-2015-03710
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/26/2013
Device MODEL Number103
Device LOT Number201943
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/05/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2011
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: 02/02/2015 Patient Sequence Number: 1
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