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

Model Number 300-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); Tissue Breakdown (2681); Fluid Discharge (2686); No Information (3190)

Event Date 10/31/2018

Event Type  Injury  

Event Description

It was reported by the patient that his chest incision site was not healing well.Further information was received from the surgeon's office that the generator has started to erode out of the skin.Surgery has been scheduled for the end of the month and it is stated that no product replacement is anticipated.Follow up with the physician clarified that the extrusion was of the lead at the chest incision site.The physician did not know the cause of the impaired healing or extrusion.He stated that the site had initially healed from the implant surgery, and then further speculated that the extrusion could be related to a small generator pocket size or migration and inadequate anchoring.No further relevant information was received to date.

Event Description

An update was received indicating that the patient's infection has now "erupted" above the generator site, not at the incision site.The physician was planning to remove the lead and generator.It was confirmed that the patient's generator and lead were explanted.Plans to reimplant the vns would wait until the infection was cleared and fully healed.No additional, relevant information was received to date.

Event Description

The patient underwent a generator repositioning surgery.Pre-operative diagnostics indicated that the device was performing as intended.During the surgery, it was noted that the generator was positioned in a way where the lead that was coming out of the generator went "straight up and made a sharp 'u'-shaped bend straight back down".This bend wore through some of the incision site and was partially exposed.The surgeon removed some tissue around the exposed area and expanded the pocket for better fit of the generator.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.This abraded opening was reported in mfg report #1644487-2018-02373.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.

Manufacturer Narrative

Patient codes, corrected data: follow-up report #2 inadvertently left out coding to capture unspecified adverse event.

Event Description

Clinic notes were received as part of the surgery referral process, and follow-up indicated that the reason for surgical referral was due to the patient having an infection.It was noted that the patient had a surgery on 01/04/2019 for the vns and the generator was repositioned.He then began seeing some swelling at the surgical site and reported that the wound was aspirated and was given antibiotics.Around 01/15/2019, the wound began to drain; the patient had kept it clean and put patches over the wound, but yellowish fluid was secreting out.The patient was therefore referred for surgery, stated to be for replacement.Device diagnostics were 1197ohms, and no setting changes were made as there is drainage from the surgical site.An update was then received stating that the physician was not willing to explant vns at this time, and that the patient currently remains on antibiotics.Device history records were reviewed for the implanted generator and confirmed that the device was sterilized prior to distribution.No known replacement or explant surgery has occurred to date.No additional, relevant information was received to date.

Event Description

Images were received of sores excreting red fluid.The location of the sore could not be confirmed from the images.The patient previously had sores as well, which were attributed to keppra), and after the recent repositioning surgery, the patient stated that the sores had not gone away and believed they were caused by vns.Clinic notes were received indicating that the patient had some swelling at the surgical site and reported that the wound was aspirated and antibiotics were started.About two weeks later, the wound started to drain with yellow-ish fluid.The physician planned to have the device explanted and then reimplanted at a later date.No known additional surgery has occurred 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: 8095325
• MDR Text Key: 128062983
• Report Number: 1644487-2018-02130
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 11/29/2018; 01/23/2019; 02/13/2019; 03/29/2019
• Supplement Dates FDA Received: 12/20/2018; 02/14/2019; 03/11/2019; 04/16/2019
• 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 Outcome(s): Other
• Patient Age: 67 YR