MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/27/2022

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 had a surgical revision.This event is a serious adverse event and is noted to have causal relationship to implant procedure and/or vns device.It was later clarified the patient reported wound healing disorder on the left neck.According to the patient, purulent liquid had recently escaped from the wound.The patient had surgical procedure.The procedure was uncomplicated, intraoperatively there was no evidence of an infection.Nothing was changed on the generator and the electrode, ultimately nothing could be found intraoperatively that confirmed the information provided by the patient.Even the scars were harmless.There was no association with vns stimulation.It is unknown if the device is still implanted or if it was removed.No other relevant information has been received to date.

Event Description

The facility later confirmed that the device is still in place; it was not removed or replaced during the surgery.

Event Description

It was later reported that the surgical revision of vns had a causal relationship with implant and procedure.This was not related to stimulation/device, concomitant medication, primary condition being treated, or other medical condition.It was not an unanticipated serious adverse event.Action was taken in the form of surgery and the event has resolved and patient recovered.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• 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: 14892135
• MDR Text Key: 295221364
• Report Number: 1644487-2022-00796
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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
• Report Date: 12/09/2022

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: 09/29/2023
• Device Model Number: 303-20
• Device Lot Number: 6426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/20/2022; 11/16/2022
• Supplement Dates FDA Received: 08/11/2022; 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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): Other
• Patient Age: 31 YR
• Patient Sex: Female