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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 01/01/2019
Event Type  Injury  
Event Description

It was reported that a patient who was implanted is being titrated biweekly and was doing better when she reached about 1. 0ma but still having 3-5 seizures/day compared to 10 seizures a day. Physician continued to increase current and when patient reached 1. 50ma-2. 0ma her seizures staring increasing dramatically, and the patient was hospitalized in the icu. Medications were adjusted and the current was decreased to 1. 0 ma. It was reported that the patient is doing better at these parameters and with the medication changes. The patient was diagnosed with ring chromosome 20. Information was received that the patient's increase in seizures was above pre-vns baseline levels. The physician thinks the seizures are related to vns stimulation especially since when she lowered it to 1. 0ma from 2. 0 her seizures decreased. No additional or 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8403580
Report Number1644487-2019-00439
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number005866
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/28/2018
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: 03/08/2019 Patient Sequence Number: 1
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