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

Model Number 7304-20

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

Patient Problem No Code Available (3191)

Event Date 10/23/2019

Event Type  Injury  

Event Description

Patient presented with a neck burn that was noted to have been possibly related to the vitaria implant.The neck burn was then clarified to have been either an allergic reaction or from an electrocautery electrode.No other relevant information has been received to date.

Manufacturer Narrative

D6.Corrected data, initial report: implant date was inadvertently listed incorrectly.

• Brand Name: LEAD MODEL 7304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9371205
• MDR Text Key: 167855175
• Report Number: 1644487-2019-02305
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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 Expiration Date: 10/18/2022
• Device Model Number: 7304-20
• Device Lot Number: 5959
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR