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

Model Number	8103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr?: device evaluation is not necessary as the sepsis is not related to the functionality or delivery of therapy of the device.
Event or Problem Description
It was reported that a few days after vns implant the patient was found on the floor and was septic.The patient was taken to the hospital and was put on antibiotics and is doing well now.Device history record was reviewed for both the generator and lead.Both devices were sterilized prior to distribution, and there were no unresolved nonconformances found prior to distribution.No additional relevant information has been received to date.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.
Event or Problem Description
Clinic notes were received from the patient's hospital admission due to sepsis.There was no direct relationship between the vns implant surgery and the sepsis identified in the clinic notes; however, the notes did read, "patient recently had a vagal nerve stimulator placed on the left.This was followed by sepsis due to bacteremia." it was also noted that the patient has a history of high concern for sepsis.It is unclear if this is attributing the sepsis to surgery, or simply reporting the chronology of events.No additional relevant information has been received to date.
Event or Problem Description
Additional notes were received regarding the patient's discharge papers.The notes indicate that the patient has a history of syncope and vision changes w/ generalized pain for years prior, and the patient's mother made her go to the emergency department due to concerns of a "bad job" with surgery.The patient presented to the ed with generalized weakness and lethargy, and was found to be hypovolemic/hypotensive.The infection workup returned negative, though the patient was noted to have been treated for a recent infection at an outside hospital (likely reported sepsis).The patient also was reported to have had elevated troponins, and cardiac catheterization showed lad disease.The patient was discharged with a cardiac care plan for lad disease.Therefore, it appears that the hypotensive and hypovolemic symptoms were attributed to cardiac issues, and the reported sepsis was treated at a different hospital/is unrelated to the cardiac issues assessed.There is no evidence that the cardiac issues are alleged against or attributed to the vns, nor are they assessed as related to the sepsis.No additional relevant information has been received to date.
Additional Manufacturer Narrative
B5 describe event or problem, corrected data: supplemental report #01 inadvertently did not include information from additional clinic notes received.

• Brand Name: SYMMETRY GEN MODEL 8103
• Common Device Name: 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 Key: 12455516
• Report Number: 1644487-2021-01282
• Device Sequence Number: 5088024
• Product Code: MUZ
• UDI-Device Identifier: 05425025750511
• UDI-Public: 05425025750511
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/05/2023
• Device Model Number: 8103
• Device Lot Number: 205576
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 12/02/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 11/16/2021; 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 42 YR
• Patient Sex: Female