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 Problems Foreign Body Reaction (1868); Inflammation (1932); Thrombosis/Thrombus (4440); Subcutaneous Nodule (4548)

Event Date 02/09/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced thrombosis of the right and left internal jugular vein.The event was noted to be probably related to the implant and not related to stimulation.It was also noted to be possibly related to underlying disease as the patient has slow flow due to heart failure.The event was noted to be moderate.Medication was provided and the event is recovering/ resolving.It was also reported that the patient had inflammation which was noted to be probably related to implant.It was noted to be a serious adverse event and is recovering/ resolving.No further relevant information has been received to date.

Event Description

It was noted that the thrombosis resolved.It was noted that there was an inflammatory mass ipsilateral to the implantation side.The event is severe and life threatening and started on (b)(6) 2021.It was noted to be probably related to the implant, not related to underlying disease or other study procedure.The event required medication and hospitalization, and it is recovering/resolving.Other contributing factors were noted to be possible thrombophilia and collagen disorder.Summary was given of the events.It states that the patient was implanted on (b)(6) /2021 and had jugular vein thrombosis, and on (b)(6)2021 the patient was treated with the anticoagulation drug ribaroxaban.The patient initially had improvement but had worsening of facial swelling on 5/5/2021 and had a ct on 5/16/2021 which showed inflammatory mass in the right neck area which was not present before.The patient had exploratory laryngoscopy and biopsy, and the patient was intubated and stable in the icu on 5/18/2021.No further relevant information has been received to date.

Manufacturer Narrative

Health effect - impact code :f2203.

Event Description

It was noted that the inflammatory mass resolved.No further relevant information has been received to date.

Event Description

It was noted that the thrombosis event is possibly related to stimulation, probably related to implant.No further relevant information has been received to date.

Event Description

The event date for the facial edema was updated.The event is noted to be probably related to implant, possibly related to device.No further relevant information has been received to date.

Event Description

Information was received noting that the patient has a disturbing cough with vns stimulation.It was also observed that he has more intense facial edema so he was referred to have a new echo to check his jugular veins again.It is noted that the edema is possibly related to implant as it happened after implantation for the first time in his life, but it is also possible that the nerve stimulation is causing inflammation.No action was taken for the events.Other events noted were thrombosis of jugular veins bilateral, possibly related to implant; thrombus size increase in cervical echo possibly related to implant, present thrombus / no evidence of another etiology; worsening of thrombosis in cervical echo and ct scan, possibly related to implant.Worsening of thrombosis began after inflammation.No further relevant information has been received to date.

Event Description

It was noted that medication was provided for the facial edema.Thrombosis of jugular veins bilateral resolved.The increase in thrombus size and coughing events had stop dates added.No further relevant information has been received to date.

Manufacturer Narrative

Correction: g3 (aware date) for supplemental report #7 should have been (b)(6) 2022.

Event Description

The increased thrombus size event was updated to "not recovered/resolved".No further relevant information has been received to date.

Event Description

Final assessment of the event of inflammation mass ipsilateral to the implantation site was probably related to the vitaria implant.The report of facial edema was updated to note that no treatment was required for the event.No additional relevant information has been received.

• 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: 11901472
• MDR Text Key: 253176064
• Report Number: 1644487-2021-00737
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/28/2022

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: 05/05/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 06/01/2021; 07/13/2021; 08/01/2021; 10/21/2021; 12/02/2021; 12/27/2021; 12/27/2021; 06/06/2022; 12/27/2021
• Supplement Dates FDA Received: 06/16/2021; 07/13/2021; 08/26/2021; 11/15/2021; 12/16/2021; 01/21/2022; 02/25/2022; 06/16/2022; 10/28/2022
• 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; Other
• Patient Age: 55 YR
• Patient Sex: Male