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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON SYMMETRY GEN MODEL 8103; GENERATOR

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CYBERONICS - HOUSTON SYMMETRY GEN MODEL 8103; GENERATOR Back to Search Results
Model Number 8103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Depression (2361)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
 
Event Description
An adverse event of worsening depression was reported for the patient and noted to have a mild severity and possibly related to stimulation.The outcome of the event is not recovered/not resolved.No other relevant information has been received to date.
 
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Brand Name
SYMMETRY GEN MODEL 8103
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
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key19014964
MDR Text Key339055756
Report Number1644487-2024-00374
Device Sequence Number1
Product Code MUZ
UDI-Device Identifier05425025750504
UDI-Public05425025750504
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 Study,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number8103
Device Lot Number7756
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received04/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2023
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 Age63 YR
Patient SexMale
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