MAUDE Adverse Event Report: UNKNOWN RV LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 0292-59

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

Oversensing seen on rv electrogram.Recent lead integrity alert from device on (b)(6)2021.Electrograms showed noise on the rv lead.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535573
• MDR Text Key: 321436924
• Report Number: MW5142469
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 0292-59
• Patient Sequence Number: 1