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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2016
Event Type  Malfunction  
Event Description

It was reported that the patient was experiencing an increase in depression due to the vns being ¿non-functional¿ for the past three years. It was clarified that the vns was thought to be non-functional due to the increase in depression and the patient not perceiving stimulation. It was stated that the patient would perceive stimulation for a while after the vns was interrogated, programmed, or had diagnostics performed, but after a couple of days, the patient would no longer perceive stimulation. Follow up with the physician revealed that the vns was checked the previous year and no problems were identified with the device functionality. The surgeon had offered to replace the vns, but the patient declined replacement. The patient was seen again recently and the diagnostics were within normal limits. It was noted that the patient had pretty severe depression and dementia. The dementia was not attributed to the vns. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key8175410
Report Number1644487-2018-02333
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/28/2010
Device MODEL Number102
Device LOT Number200948
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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