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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2021

Event Type  malfunction  

Event Description

Patient presented with high lead impedance.X-rays were ordered; however, have not been reviewed by the manufacturer to date.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Implant card for the patient was received noting a full revision was performed and less than 2cm of the previous lead was left.It was indicated that the lead was not available for return.No additional 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: 11283328
• MDR Text Key: 230449561
• Report Number: 1644487-2021-00163
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2013
• Device Model Number: 302-20
• Device Lot Number: 201160
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR