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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 (2993)
Patient Problem Anxiety (2328)
Event Date 12/31/2007
Event Type  Injury  
Event Description
It was reported that patient had her vns turned off around 2007 and 2009 because she had two deaths and close friend and mentally couldn't handle vns.She thought it was the reason for her mental instability.No additional relevant information has been received to date.
 
Event Description
It was reported that patient had her vns turned off around 2007 and 2009 because she had two deaths and close friend and mentally couldn't handle vns.She thought it was the reason for her mental instability.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 102
Type of Device
GENERATOR
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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key13370927
MDR Text Key285392017
Report Number1644487-2022-00073
Device Sequence Number1
Product Code MUZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2007
Device Model Number102
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 01/04/2022
Initial Date FDA Received01/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
Patient SexFemale
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