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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient went to the emergency department due to feeling painful stimulation in her chest and right eye for the past 5 days. The patient was informed how to use the magnet to disable the device, but it was unknown if that was done. Attempts for further information were unsuccessful to date.

 
Event Description

The patient reported that she was having pain around her generator site and sometimes had a lead pulling situation. She stated that it had been happening for a long time. She was instructed on how to use the magnet to disable the device, and she said that she hadn't tried that yet. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key6530315
Report Number1644487-2017-03689
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 04/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/03/2018
Device MODEL Number106
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/24/2016
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: 04/28/2017 Patient Sequence Number: 1
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