MAUDE Adverse Event Report: MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 5568

Device Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the following physician, dr.(b)(6), was concerned with this right atrial (ra) lead integrity.Insulation damage was suspected, and while in the pocket, conductor separation was found.The lead was left in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17519777
• MDR Text Key: 321324092
• Report Number: MW5126725
• 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: 08/28/2019

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: 5568
• Patient Sequence Number: 1