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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported to a company representative that a vns patient was experiencing painful stimulation with the device. Clinic notes were received from a visit on (b)(6) 2017. The notes described that the patient was experiencing irritation with vagus nerve stimulation cycles. The battery was reported to be at full capacity and there was no ¿weak¿ impedance. During the clinic visit on (b)(6) 2017, it was decided to tape the magnet in place to stop stimulation and assess if the painful stimulation resolves. The patient also wanted to continue referral for surgery in the meantime. The provider stated that they had wrapped the magnet in place themselves during the visit. Follow-up from the physician provided that the painful stimulation did not resolve after the magnet had been taped in place. The patient was scheduled for surgical consult, but no known surgery has occurred to-date. Additional relevant information has not been received to-date.

 
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Brand NamePULSE GEN MODEL 103
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6376264
Report Number1644487-2017-03309
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2014
Device MODEL Number103
Device LOT Number3287
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/06/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/13/2012
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: 03/03/2017 Patient Sequence Number: 1
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