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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Malfunction  
Event Description

The patient reported that they are having very frequent "black outs" but is unsure if they are seizures or not. The patient has indoor cameras and when reviewed , there is no outward appearance of seizures, but it was stated that they just appear to be dead on camera, and the patient's latest blackout lasted for several days. The patient recently had a fall during one of the blackouts. The patient stated that the vns has never helped her. Additional information was received from the patient's previous neurologist who stated that they have not seen the patient since 2014, and there was no mention previously of the patient's black out events. It was stated that there is mention in the notes that the patient's vns stimulation was increased in (b)(6) 2013. It was stated that they didn't have any additional information. The patient reported that they have not seen a neurologist in over 3 years, and is currently only seeing their pcp. The patient is experiencing an increase in seizures which was described as dropping back as though dead where the patient is unconscious. The patient stated that she recently went to the er in response to one of these seizures. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key7792799
Report Number1644487-2018-01424
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/17/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/13/2014
Device MODEL Number103
Device LOT Number3540
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/17/2018 Patient Sequence Number: 1
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