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

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems Wound Dehiscence (1154); Chest Pain (1776); Unspecified Infection (1930)

Event Date 11/23/2017

Event Type  malfunction  

Event Description

A patient's device was causing him discomfort.High lead impedance was observed on the patient's device.The patient also reportedly had an external skin wound that may have been caused by the vns.The patient's device was programmed off in response.X-rays were performed and reviewed by the physician and reportedly did not identify a lead break or other abnormality.A company representative reported that the pain may be a result of stimulation.The physician suspected that the patient's wound had become infected.At a subsequent visit, the patient's wound had improved significantly since the device was disabled.The company representative confirmed this via assessment of updated pictures of the wound.The patient was given antibiotics.Lateral neck x-rays of the patient's device were reviewed by the manufacturer.Only a small portion of the lead was visible in the images, and the generator was not visible in the x-ray images provided.The lead was observed in the neck.The strain relief bend was present, but a strain relief loop did not appear to be completed.Two tie-downs appeared to be securing the lead past the strain relief bend.No sharp angles or discontinuities were observed in the images.Ap neck and chest x-rays and lateral chest x-rays were later reviewed by the manufacturer.Due to the angle of the generator in the image, proper lead pin insertion could not be assessed.The filter feedthru wires appeared intact.The lead was observed in the neck, and the electrodes appeared to be placed per labeling.The strain relief bend was present, but a strain relief loop did not appear to be completed.No sharp angles or discontinuities were observed in the visible portion of the lead.A portion of the lead was routed behind the generator and could not be assessed.The cause of the patient¿s high impedance could not be determined with the x-ray images provided.The device history records were reviewed for the lead and generator and revealed that both devices met all sterilization and functional specifications for release prior to distribution.The physician did not believe that patient manipulation of the device caused the external wound and infection.The patient was referred for surgery to resolve the high impedance, but no surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent exploratory surgery.It was determined that fluid was observed in the lead, causing the surgeon to suspect a lead fracture.High impedance was observed on both system and normal mode diagnostic tests.The patient was referred for lead and generator replacement surgery, but no additional surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that explant occurred on the generator due to the lead break on the left side, leads were not able to be explanted.The fractured lead was unable to be explanted.Therefore, the product cannot be returned for evaluation.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 7132107
• MDR Text Key: 95595370
• Report Number: 1644487-2017-05046
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2017
• Device Model Number: 302-20
• Device Lot Number: 3604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2013
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male