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

Model Number 300-20

Device Problem Mechanical Problem (1384)

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

Event Date 11/29/2018

Event Type  malfunction  

Event Description

During the generator repositioning surgery for lead extrusion reported in mfg report #1644487-2018-02130, it was noted during the surgery that just below one of the lead pins, scar tissue had formed in the shape of a tube around the pin's wire.It was stated that within the tube, the lead wire had a portion that was exposed with the insulation pulled back.Diagnostics were performed outside the pocket noting impedance within normal limits.The generator was then positioned and secured into the pocket.Another diagnostic was performed with ok impedance and the pocket was closed.No additional relevant information was received to date.

Event Description

It was stated that the patient had a battery replacement on (b)(6) 2017, and the surgeon went back into the chest pocket in (b)(6) 2018 to attempt to correct an infection.No replacement occurred.It was stated that now the patient has an infection that has "erupted" above the generate site, not at the incision site.The physician was planning to remove the lead and generator.It was confirmed that the generator and lead were explanted due to the infection.No device was to be returned for analysis.No device was received to date.No additional, relevant information was 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8188205
• MDR Text Key: 131154842
• Report Number: 1644487-2018-02373
• Device Sequence Number: 1
• Product Code: LYJ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2001
• Device Model Number: 300-20
• Device Lot Number: 30151C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/1999
• 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: 67 YR