MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 7304

Model Number 7304

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

Patient Problem No Code Available (3191)

Event Date 01/12/2020

Event Type  Injury  

Event Description

It was reported for a clinical trial patient that the patient experienced a neck burn with causality reported to be "probably related' to device implantation surgery, with rationale "patient got a burn on his neck, either as an allergic reaction or from the electrode of the electrocautery".It is not related to device stimulation or system, there was no action taken with the treatment.Non-drug treatment was required.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 7304
• 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: 9694229
• MDR Text Key: 178586668
• Report Number: 1644487-2020-00227
• Device Sequence Number: 1
• Product Code: MUZ
• 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: foreign,health professional,s
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2020

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 Model Number: 7304
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention