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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 Problems Dysphagia/ Odynophagia (1815); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/07/2021
Event Type  Injury  
Event Description
A clinical study patient reported numbness and dysphagia that were assessed as definitely related to vns surgery, and not related to device/stimulation.It was also noted that the patient experienced "anesthesia-induced serotonin syndrome" that was "definitely related" to vns surgery, and "possibly related" to other patient condition.It was noted that the patient was hospitalized due to the numbness, dysphagia, and anesthesia-induced serotonin syndrome.No additional relevant information has been received to date.
 
Manufacturer Narrative
D4 lot # / expiration date / unique identifier (udi) #, corrected data: initial report inadvertently did not include relevant product information.H4 device manufacture date, corrected data: initial report inadvertently did not include relevant mfr date.
 
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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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key12025708
MDR Text Key257261278
Report Number1644487-2021-00850
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 Study,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/22/2021
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 Date03/09/2022
Device Model Number8103
Device Lot Number205379
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 05/26/2021
Initial Date FDA Received06/18/2021
Supplement Dates Manufacturer Received11/22/2021
Supplement Dates FDA Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2020
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) Hospitalization; Other;
Patient Age36 YR
Patient SexMale
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