MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Fracture (1260)

Patient Problems Discomfort (2330); Neck Pain (2433); Shock from Patient Lead(s) (3162)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

The physician reported that the patient presented with high impedance.The patient denies trauma to the device area and reported new onset of neck and ear pain.Ap chest and lateral neck x-rays were reviewed.The generator placement appears to be abnormal as it is in the lower left chest.The connector pins appear to be fully inserted in the generator connector blocks.The feedthru wires appear intact.The lead was visualized in the chest and neck.Strain relief and tie downs are present as per labelling.No sharp angles were observed in the lead.The lead was assessed for fractures and no gross fractures or discontinuities were noted.The lead appears intact at the connector pin.The lead is not routed behind the generator.Note that the presence of problems in obscured portions of the lead and microfractures cannot be ruled out.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The device was disabled.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The patient underwent a full revision due to high impedance.The explanted products have not been received to date.No other relevant information has been received to date.

Event Description

It was reported that the explanted products were discarded.No other relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 12977937
• MDR Text Key: 282069352
• Report Number: 1644487-2021-01730
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2000
• Device Model Number: 300-20
• Device Lot Number: 15395C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/1998
• 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: 70 YR
• Patient Sex: Female