MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

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

Patient Problem Unspecified Infection (1930)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr?, code 81: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that a patient had an infection at the neck site that was about the size of a golf ball.It was stated that the patient had picked at the site and has had an infection for about two weeks.The physician prescribed antibiotics.No additional, relevant information was received to date.

Event Description

Further information was received that the surgeon had explanted the patient's generator and lead.It was noted that the electrodes were left in place.

Event Description

Patient presented in clinic with a bump and slightly opened wound as a result of the infection.The patient was referred to a surgeon for further assessment of the wound.Design history records for the generator and lead were reviewed.The generator and lead were confirmed to have been hp sterilized prior to distribution into the field.The devices passed all specifications.

• Brand Name: LEAD MODEL 302
• 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: 8338214
• MDR Text Key: 136110541
• Report Number: 1644487-2019-00301
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/29/2010
• Device Model Number: 302-20
• Device Lot Number: 1948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2007
• 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: 47 YR