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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Malfunction  
Event Description

Report received that a patient had experienced left chest pain. Since the pain began, the patient also experienced 7 seizures which was reportedly more than he typically experienced. It was not known if this was above pre-vns seizure frequency. The patient reported these symptoms to his implanting surgeon who was able to check the functionality of the vns system and found that it was operating as expected. The manufacturer representative was also present at this time he reportedly swiped the magnet to a activate magnet mode stimulation and the patient did not report feeling any pain at that time. Blood-work and x-rays were taken to rule out other causes of the issues. The patient reportedly did not recall any event that would have caused strain or trauma to the left shoulder/chest area. The surgeon reportedly did not believe the pain had anything to do with the vns, but the patient was to follow-up with his neurologist. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key7705975
Report Number1644487-2018-01216
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/27/2017
Device MODEL Number106
Device LOT Number4614
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/12/2015
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: 07/20/2018 Patient Sequence Number: 1
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