MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 03/17/2017

Event Type  Injury  

Event Description

It was reported that a vns patient had a retained suture, and was referred for surgery to revise the incision and remove the suture.The skin over the subcutaneous anchor was thinning and surgery was scheduled to prevent skin breakdown.Follow-up from the company representative who attended the surgery provided that a stitch through one of the tie downs was placed too shallow for such a small patient and had worked through the skin.There was no issue with the lead or any of the anchors.The stitch was removed and the tie-down cleaned up from some infection.Review of the manufacturing records confirmed the lead and generator were sterilized prior to distribution.Additional relevant information has not been received to-date.

Manufacturer Narrative

Date of event, corrected data: the date of event was inadvertently provided incorrectly on the initial mdr.

Manufacturer Narrative

Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.

Manufacturer Narrative

Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on follow-up report #2.

• Brand Name: LEAD MODEL 303
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6957232
• MDR Text Key: 89561890
• Report Number: 1644487-2017-04638
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2020
• Device Model Number: 303-20
• Device Lot Number: 5082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2016
• 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: 13 YR