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

Device Problem Fracture (1260)

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

Event Date 01/13/2021

Event Type  malfunction  

Event Description

It was reported the patient was observed to have high impedance.It was believed the lead had fractured.Xrays were taken and reported to be suboptimal due to patient cooperation.Patient is being called back in for more xrays.No additional relevant information has been received to date.

Manufacturer Narrative

D1.Brand name - correction - bipol lead model 300 should have been included h4.Manufacture date - correction - ni should have been used in initial mdr.

Event Description

Xray images were reviewed.In the portions of the lead visible, no gross lead fractures or other anomalies were observed.High impedance was noted to persist with no symptoms.No known surgery has occurred to date.No additional relevant information has been received to date.

Event Description

Patient underwent full revision surgery.The explanted products were noted to have been discarded.

Event Description

During the full revision surgery the m104 generator was first replaced with a m1000 duo generator and high impedance was still seen so the lead was replaced as well.

Manufacturer Narrative

B5 describe event or problem, corrected data: follow-up report #2 inadvertently forgot to list details that occurred during the full revision surgery.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11279989
• MDR Text Key: 230323873
• Report Number: 1644487-2021-00155
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/05/2021

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/12/2021; 05/20/2021; 08/05/2021
• Supplement Dates FDA Received: 03/02/2021; 06/14/2021; 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR