MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

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

Patient Problem Unspecified Infection (1930)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description

At the patient's first follow-up appointment after implant surgery, the patient stated feeling discomfort at the neck area.The physician initially believed to be a side effect of the implant procedure and did not believe there was an infection.Upon another appointment with the physician, it was stated the patient suspects an infection at the incision site.The patient was prescribed antibiotics.Device history records were reviewed for the implanted devices and both devices were sterilized and passed all quality inspections prior to distribution.No further relevant information has been received to date.

Manufacturer Narrative

Age at time of event.Corrected data.Initial report inadvertently listed the incorrect age.

Event Description

Follow-up with the physician clarified that the infection was confirmed at the chest incision site and the patient's pain was related to the infection.The physician stated that the possible cause of the infection was possible poor hygiene, and that the infections improved with antibiotics.No additional relevant information was received to date.

• Brand Name: LEAD MODEL 304
• 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: 7836153
• MDR Text Key: 118865812
• Report Number: 1644487-2018-01538
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2021
• Device Model Number: 304-20
• Device Lot Number: 5238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2017
• 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: 56 YR