MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2023

Event Type  malfunction  

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 was seen with high impedance.Further information was received from the nurse practitioner that x rays have not been taken and patient will be referred to surgeon.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B3.Corrected data, event date; initial report inadvertently listed wrong date.

Event Description

The event date is 02/20/2023, the initial mdr submitted the wrong event date in error.

Event Description

It was later reported patient had lead revision surgery.During surgery, the surgeon noticed that the electrodes were not placed on the vagus nerve but were wrapped around something else, possibly the ansa cervicalis nerve.The surgeon also noted a clear break in the lead insulation in the upper portion of the lead, which would have been the cause of the high impedance.Following the surgery it was noted that the explanted lead serial number did not match the device on record.The explanted device has been received into product analysis.No other relevant information has been received to date.

Event Description

Product analysis has been completed and the fracture was confirmed.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16553634
• MDR Text Key: 311675254
• Report Number: 1644487-2023-00309
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2009
• Device Model Number: 302-20
• Device Lot Number: 1538
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2006
• 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 Age: 67 YR
• Patient Sex: Female