MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 7304

Model Number 7304-20

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

Patient Problem Hematoma (1884)

Event Date 10/07/2022

Event Type  Injury  

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

It was reported that patient experienced a serious adverse event of hematoma neck right side.The event is possibly related to implant procedure.The outcome has not recovered/not resolved.The event of hematoma neck right side met serious adverse event criteria because the event required hospitalization or prolonged hospitalization.No other relevant information has been received to date.

Event Description

It was later reported that they believed the hematoma was possibly related to vitaria implant since it occurred a few days after implant surgery.No action was required with study treatment for hematoma.Medication and hospitalization were required for the hematoma.The event has not resolved.Patient called site before his visit and told that he has been readmitted due to bleeding on the neck right side.Clinic notes noted that post-operatively sonography ruled out active bleeding.A large soft tissue hematoma was seen in the right neck area.Clinically, the neck was swollen on the right side, but soft with visible hematoma extending to the chest.The hematoma is visible around the lower neck margin and above the device bag.Patient was readmitted because he experienced progressive soft tissue swelling at the lower edge of the neck.The hematoma developed under marcumar therapy.Under inpatient monitoring, the hematoma was already declining, so they paused marcumar paused.The patient was discharged home a few days later.It was noted that the patient was discharged home with good performance status and subjectively improved condition therefore released for outpatient care with follow-up checks on hematoma needed.The event has not yet been noted to have resolved/recovered.

Manufacturer Narrative

F2.Report source; corrected data; initial mdr inadvertently omitted information known prior to submission.

Event Description

It was later reported that the event of hematoma neck right side has resolved and patient has recovered.

• Brand Name: LEAD MODEL 7304
• Type of Device: LEAD
• 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: 15708986
• MDR Text Key: 302782671
• Report Number: 1644487-2022-01360
• Device Sequence Number: 1
• Product Code: LYJ
• 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
• Report Date: 02/02/2023

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: 07/16/2023
• Device Model Number: 7304-20
• Device Lot Number: 204982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/02/2022; 01/05/2023
• Supplement Dates FDA Received: 11/17/2022; 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male