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

Model Number 8103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Local Reaction (2035); Unspecified Heart Problem (4454); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2023

Event Type  Injury  

Event Description

It was reported that the patient was experiencing heart abnormality and suspected gall stones.These adverse events were noted to be probably related to stimulation.Additional information was received noting that intervention for suspected gall stones were taken in the form of diagnostic exams and added medication.Intervention for heart anomalies were noted to be diagnostic examinations.Both adverse events are noted to still be recovering/resolving.No other relevant information has been received to date.

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿cholecystitis" is not available.This report was due on november 25, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 20, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.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 was received noting that the adverse event term for the reported heart abnormality is now abnormal ekg reading and is now possibly related to stimulation no other relevant information has been received to date.

Event Description

Additional information was received noting that the previously reported adverse event of abnormal ekg reading is now noted to be abnormal hearth rhythm, rhythm unknown.The adverse event of suspected gall stones is now noted to be not related to vns therapy or surgery no other relevant information has been received to date.

Event Description

The adverse event previously listed as "abnormal heart rhythm, rhythm unknown" has been updated to "thickening of heart walls".This is noted to be not related to surgery or the presence of the device and possibly related to stimulation.This adverse event required the use of medication.No other relevant information has been received to date.

• 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 Key: 18270864
• MDR Text Key: 329759008
• Report Number: 1644487-2023-01734
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/29/2024

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 Date: 10/12/2023
• Device Model Number: 8103
• Device Lot Number: 6999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 01/10/2024; Not provided
• Supplement Dates FDA Received: 12/22/2023; 02/01/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female