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

Model Number 303-20

Device Problems Fracture (1260); High impedance (1291); Device Contamination with Body Fluid (2317); Naturally Worn (2988)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

Patient was seen and the generator showed high impedance when interrogated.Programmed output current was unable to be delivered.No known surgery has occurred to date.No additional relevant information has been received.

Manufacturer Narrative

F10.Medical device code- correction - code a040101 should have been included in initial mdr in place of code a072201.H5.Investigation findings - correction - code c070603 should have been included in initial mdr in place of code c0203.H5.Investigation conclusions - correction - code d02 should have been included in initial mdr in place of code d14.

Event Description

Patient is still experiencing high impedance.Xrays were taken; however, no issues were observed.Patient was noted to still be feeling stimulation.No known surgery has occurred to date.No additional relevant information has been received to date.

Event Description

Patient underwent lead replacement due to high impedance.The replacement resolved the high impedance.The explanted lead was returned and received for analysis, though has not been completed yet.No other relevant information has been received to date.

Event Description

Lead analysis was completed.No additional relevant information has been received.

• 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: 12824254
• MDR Text Key: 282566247
• Report Number: 1644487-2021-01602
• 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,Followup
• Report Date: 06/28/2023

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: 03/26/2016
• Device Model Number: 303-20
• Device Lot Number: 202089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Event Location: Other
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/08/2021; 05/13/2022; 04/17/2023; 06/22/2023
• Supplement Dates FDA Received: 12/08/2021; 05/20/2022; 05/12/2023; 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2012
• 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: 59 YR
• Patient Sex: Male