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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
Device Problem Insufficient Information
Event Type  Injury  
Event Description

It was reported that this patient's vagus nerve was damaged, it never helped her seizures and it made her hiccup constantly. It was also reported that the patient could feel the electrical pulse in her throat. No other relevant information has been received to date.

 
Manufacturer Narrative

Date received by manufacturer, corrected data: 08/31/2017. Initial report inadvertently listed the aware date as 09/01/2017 instead of 08/31/2017.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6891887
Report Number1644487-2017-04489
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/28/2017
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: 09/25/2017 Patient Sequence Number: 1
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