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

Model Number 302-20

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/22/2020

Event Type  Injury  

Event Description

It was reported that the patient was scheduled for a repositioning of her vns on left vs right side placement due to an unknown reason, implying a potential adverse event.No further relevant information has been received to date.

Event Description

An implant card was received reporting the patient's surgery.The implant card indicated that the patient's generator was removed in the past and that the patient's lead was replaced and device damaged due to trauma/abuse.Based on the manufacturer's available device/patient information, the patient's last known generator and part of the lead was removed due to infection in 2009 (as captured in mfr report 1644487-2010-00152.).No further relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10693308
• MDR Text Key: 211844500
• Report Number: 1644487-2020-01392
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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 Expiration Date: 12/09/2011
• Device Model Number: 302-20
• Device Lot Number: 2239
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR