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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 01/18/2007
Event Type  Injury  
Event Description

Reporter indicated that a vns patient had bradycardia with vns stimulation. The vns was disabled on (b)96) 2007 and the bradycardia resolved. The vns has been disabled since this date, and will remain disabled at the reporter's discretion. The patient does not have a pre-vns history of bradycardia. Medication therapy will be utilized for the patient's seizure control. The bradycardia was felt to be due to the normal delivery of vns stimulation. It was not known if the patient had been referred to a cardiologist at the time the bradycardia occurred.

 
Event Description

Exploratory surgery for the patient to verify if the vns electrodes are aligned properly on the nerve is likely, but has not occurred to date. It is also possible a new vns lead and generator will be implanted.

 
Event Description

It was reported that the patient has been referred for generator and lead replacement. The physician believes that the electrodes were not placed correctly due to the patient suffering life-threatening bradycardia when initially implanted. No known surgical interventions have been performed to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key2052578
Report Number1644487-2011-00760
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/25/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2007
Device MODEL Number102
Device LOT Number015168
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2005
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: 04/08/2011 Patient Sequence Number: 1
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