MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problems High impedance (1291); Appropriate Term/Code Not Available (3191)

Patient Problems Seizures (2063); Cognitive Changes (2551); No Information (3190)

Event Date 11/06/2019

Event Type  malfunction  

Event Description

It was reported that the patient was hospitalized due to the patient's lead being loose and not working.It was indicated that neurology checked the patient's device and mri was performed on the patient.During follow-up with the mri technician who reported the event, it was stated the information came from the patient.At this time, since no additional details are known the report of the lead being loose is being considered migration and an unspecified adverse event since the patient was hospitalized for it.The device history record's of the lead was reviewed.The lead passed final quality and functional specifications prior to release.No additional relevant information has been received to date.

Event Description

Additional information was received from the treating physician of the patient when they were hospitalized.It was indicated that the patient was having behavioral changes that may be due to breakthrough seizures; however, the relatedness to vns is unclear.It was stated that vns had high impedance and that there was kinking of the distal tip of vns lead without any visualized lead fracture.It was stated that the hospitalization of the patient was to determine the etiology of the behavioral changes and treat it accordingly.

• Brand Name: LEAD MODEL 304
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9383888
• MDR Text Key: 168252020
• Report Number: 1644487-2019-02319
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2023
• Device Model Number: 304-20
• Device Lot Number: 204777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• 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: 31 YR