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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/02/2012
Event Type  Injury  
Event Description

It was reported that a patient was experiencing blackouts due to higher settings with her vns device. The device was turned off on (b)(6) 2012 as a result. It was reported the patient had to have five surgeries because of this and does not want the device turned back on. A review of the manufacturer¿s in-house programming history showed the device was within normal limits. Additional relevant information has not been received to-date.

 
Event Description

Follow-up to the physician¿s office regarding the blackouts and the surgeries only provided information that the patient does not want to have the device turned back on.

 
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Brand NamePULSE GEN MODEL 103
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 Key6261271
Report Number1644487-2017-03048
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/15/2012
Device MODEL Number103
Device LOT Number2723
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/15/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2010
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: 01/18/2017 Patient Sequence Number: 1
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