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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 06/01/2017
Event Type  Injury  
Event Description

It was reported that the patient was having chest pains. It was unclear if the pain was due to the vns. The patient was taken in an ambulance and abnormal ecg was observed. The patient had no past abnormal ecgs. It was recommended to the patient to contact her neurologist to run diagnostics. Follow up with the physician's office revealed that the patient had contact the office. It was reported that they were aware of the event, but did not have information. 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 Key6684184
Report Number1644487-2017-04080
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/14/2017
Device MODEL Number106
Device LOT Number4582
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/09/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/26/2015
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: 07/03/2017 Patient Sequence Number: 1
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