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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
Event Date 11/01/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported on 11/07/2016 that the patient is experiencing an more intense seizures including new drop seizures. She is having some drop seizures which she had not had in the past. There were no other factors that were thought to have caused the increase or new seizure type except a medication change which was a drop in topamax from 7. 25 mg tablets to 6 mg tablets. Patient would not sit still long enough to run diagnostics.

 
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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 Key6143223
Report Number1644487-2016-02783
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Report Date 11/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/03/2018
Device MODEL Number106
Device LOT Number203749
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/07/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/06/2016
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: 12/02/2016 Patient Sequence Number: 1
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