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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported by the patient that they had experienced a different, more intense, type of seizure than normal. The patient described the seizure event as "from nothing to a very significant one" and "going from 0 to 1000" as opposed to his typical gradual seizures. The patient reported that after the varied seizure he became more aware of his stimulation and the side effects with stimulation that he had experienced with titration (discomfort and cough) came back. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 1000
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 Key8371572
Report Number1644487-2019-00367
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 02/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2019
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204571
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/02/2018
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: 02/26/2019 Patient Sequence Number: 1
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