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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 09/26/2011
Event Type  Injury  
Event Description

It was initially reported that the patient had requested that the generator be disabled. The patient had reported to the physician that she felt that her depression has been worse since having vns. The physician that reported the event's to the manufacturer is not familiar with vns and the patient so she was unable to provide any additional information. Good faith attempts for more information have been unsuccessful to date.

 
Event Description

It was later reported the patient would like to have her device explanted because the vns isn't helping and hasn't helped in years. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

 
Event Description

It was reported from the patient's mother that she is looking for a surgeon to explant the device because he never received benefit from the therapy. No additional relevant information has been received to date and no surgical intervention has occurred to date.

 
Event Description

Information was received indicating that the patient had his device disabled. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

 
Event Description

Additional information was received from the patient stating why he wants the vns removed. He states it is not helping his severe depression, it adversely affects his speech when it¿s cycling, it increases his social anxiety because he is concerned it will start cycling when he speaks, and he states the device makes it difficult to breathe when he exercises. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key2301015
Report Number1644487-2011-02502
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,COMPANY REPRESENTATIVE,CON
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2007
Device MODEL Number102
Device LOT Number14788
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/03/2005
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: 10/19/2011 Patient Sequence Number: 1
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