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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 01/08/2019
Event Type  Injury  
Event Description

Initial report was that a patient was referred for device removal due to the device not helping the patient and hurting when going off. The device was disabled. No known surgical intervention has occurred to date. No other 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 Key8296303
Report Number1644487-2019-00187
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204234
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/19/2017
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: 02/01/2019 Patient Sequence Number: 1
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