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

Model Number 303-20

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2019

Event Type  malfunction  

Event Description

It was reported that the patient had their leads revised due to "vns-linked lead malposition." it was reported that the electrode had dislocated from the nerve, caused by migration.The patient was reportedly not receiving stimulation due to the detachment and the surgeon had "issues with the anatomy of the subject." the return of the explanted lead to the manufacturer is not expected to date.No further relevant information has been received to date.

Event Description

It was reported that the device deficiency was "obvious lead break/discontinuity observed through an x-ray." it was reported that this device observation was not resolved through troubleshooting and that the lead was replaced.The subject did not experience any adverse events and the deficiency resolved with the lead revision.No further relevant information has been received to date.

Event Description

Incoming information was received that the event resolved.No further relevant information has been received to date.

Event Description

It was reported that the patient experienced suspected pain during stimulation.No further relevant information has been received to date.

Event Description

It was reported that the patient had their lead explanted due to lack of efficacy.

Event Description

Additional information received from the clinical study noting that the reported pain during stimulation now has an outcome of 'unknown'.

• 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: 9137616
• MDR Text Key: 160685485
• Report Number: 1644487-2019-01906
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2022
• Device Model Number: 303-20
• Device Lot Number: 5661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• 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: 54 YR
• Patient Sex: Male