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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 06/01/2012
Event Type  Injury  
Event Description

It was reported that the patient's device was programmed off from (b)(6) 2012 because the patient felt seizures worse and didn't like the device. The patient was at 1. 5ma when the device was programmed off. It was reported that the device was programmed back on october 2012 at 0. 5ma and no changes have been made since that time and the family "likes" the settings where they are currently. It was reported that the patient is currently doing well and no additional information will be provided. It is unknown if the worsening of seizures was above the patient's pre-vns baseline.

 
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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 Key3497444
Report Number1644487-2013-03668
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/06/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number102
Device LOT Number2393
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/06/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/02/2009
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: 12/03/2013 Patient Sequence Number: 1
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