MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 4076

Device Problems Device Alarm System (1012); High impedance (1291)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this right atrial (ra) lead exhibited impedance measurements of greater than 3000 ohms, and the patient's device had been emitting beeping tones.There had been intermittent increases in the impedance measurements over the past two months.There were no episodes of noise on the ra channel.The patient was brought in to their clinic to turn off the beeping and the patient would continue to be monitored.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 PACEMAKER ELECTRODE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17522246
• MDR Text Key: 321422502
• Report Number: MW5129194
• Device Sequence Number: 1
• Product Code: DTB
• 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: 06/06/2019

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: 4076
• Patient Sequence Number: 1