MAUDE Adverse Event Report: MEDTRONIC RA LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 4524

Device Problem Ambient Noise Problem (2877)

Patient Problems Idioventricular Rhythm (1923); Dizziness (2194)

Event Type  Injury  

Event Description

It was reported that the health care professional (hcp) requested a review of the atrial tachycardia response (atr) episodes.Upon review, of the available electrograms, it was determined that the atr episodes were inappropriate due to noise oversensed on this non-boston scientific right atrial (ra) lead.Which led to the patient experiencing lightheadedness and ventricular rhythm.Troubleshooting options were discussed.At this time, this product remains in service and 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: RA LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17488726
• MDR Text Key: 320689880
• Report Number: MW5121425
• 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: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4524
• Patient Sequence Number: 1