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

Model Number 304-20

Device Problem High impedance (1291)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

The patient was seen in clinic and presented with high lead impedance and was referred for a lead revision.Device history record was reviewed for the suspect lead.The lead passed final functional and quality specifications prior to release for distribution and no unresolved nonconformances were found prior to distribution.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient has decided to disable their device and see how they do and hold off on surgery.

• 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: 13118206
• MDR Text Key: 282966178
• Report Number: 1644487-2021-01848
• 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,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

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: 04/21/2023
• Device Model Number: 304-20
• Device Lot Number: 204890
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• 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 Age: 6 YR
• Patient Sex: Female