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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/05/2018
Event Type  Malfunction  
Event Description

It was reported by the physician that the patient had an increase in seizures, increased notably in frequency and duration compared to the 4 months prior, starting the day after surgery. Prior to implant, seizure rate was 2-4 per month and after implant, it was 1 per day. The believed cause of the increased seizure frequency and intensity was device implantation and not device stimulation as it occurred the date after surgery. There was no believed external contributing factors. The device was off at the time of onset of seizures. Diagnostics were ok at the first visit after implantation. There was no medication change as a result of this event. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8123431
Report Number1644487-2018-02189
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204520
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2018
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: 12/03/2018 Patient Sequence Number: 1
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