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

Model Number 304-20

Device Problem Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

Event Type  malfunction  

Event Description

It was reported that a diagnostic test during an office visit resulted in low impedance.It was noted that patient had not seen a recent change in seizure frequency.X-rays were ordered by the physician and the images were reviewed by the manufacturer.No anomalies or fractures were noted in the x-ray images.However, due to the quality of the images provided the lead¿s integrity was difficult to assess in some locations.There was a portion of the lead that appeared to potentially be a sharp angle however this could not be confirmed in the other x-rays images.It was noted that the lead pin appeared to be fully inserted however due to the angle of the generator the lead pin's position could not be fully assessed.No additional relevant information has been received to date.

Event Description

It was reported that had their device disabled, and are referred for explant.The patient no longer wants the device.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that the patient underwent a full revision, and the explanted products have been received by the manufacturer.No other relevant information has been received to date.

Manufacturer Narrative

B5: describe event; corrected information; initial mdr inadvertently omitted information known prior to submission.6b: if explanted, give date; corrected information; initial mdr inadvertently omitted information known prior to submission.D9: device available for evaluation?; corrected information; initial mdr inadvertently omitted information known prior to submission.

Event Description

It was reported that the patient was explanted on an unknown date.The device has not been received to date.No other relevant information has been received to date.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 6563232
• MDR Text Key: 75039223
• Report Number: 1644487-2017-03771
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Model Number: 304-20
• Device Lot Number: 3847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 09/12/2022; 10/10/2022; 11/22/2022
• Supplement Dates FDA Received: 10/07/2022; 11/04/2022; 12/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2014
• 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: 7 YR
• Patient Sex: Female