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

Model Number 300-20

Device Problem Device Contamination with Body Fluid (2317)

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

Event Type  malfunction  

Event Description

A patient had a prophylactic full revision surgery, and the explanted devices were returned for analysis.Analysis of the returned lead noted abrasion on the outer silicone tubing at multiple locations.It was also noted that there was an abraded opening identified in the inner silicone tubing of the negative coil.Dried remnants of what appear to have once been body fluids/betadine solution were located inside the inner and the outer silicone tubing due to points of entrance at abraded openings and the cut ends of the returned lead portions.Other than the inner/outer tubing abrasions and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Analysis of the returned generator identified no anomalies.No additional relevant information was received to date.

Event Description

The pre-operative session report from the day of surgery was received indicating that the previous device was functioning as intended prior to being explanted.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: 8190528
• MDR Text Key: 131206357
• Report Number: 1644487-2018-02384
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

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
• Device Expiration Date: 05/12/2004
• Device Model Number: 300-20
• Device Lot Number: 6005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2002
• 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