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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. SYMMETRY GEN MODEL 8103; GENERATOR

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LIVANOVA USA, INC. 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 11/18/2023
Event Type  malfunction  
Event Description
An adverse event of worsening depression was reported and noted to have a moderate severity and possibly related to stimulation.The outcome of the event is noted to be not recovered/not resolved.No other relevant information has been received to date.
 
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
Additional information received that intervention was taken for the reported worsening depression which was observation only.
 
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Brand Name
SYMMETRY GEN MODEL 8103
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key18470262
MDR Text Key332622311
Report Number1644487-2024-00019
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,Followup
Report Date 02/02/2024
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 Number7460
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 12/14/2023
Initial Date FDA Received01/08/2024
Supplement Dates Manufacturer Received01/10/2024
Supplement Dates FDA Received02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2023
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 Age67 YR
Patient SexFemale
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