MAUDE Adverse Event Report: ST. JUDE MEDICAL DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 1388TC

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this right atrial lead oversensed noise leading to episodes of atrial tachycardia response.The noise appeared consistent with electromechanical interference (eml).It was noted that the patient had a glucose monitor and an insulin pump.A technical services representative discussed that the noise could potentially be a result of oversensing of the respiratory rate trend (rrt) signal.Ts discussed emi considerations and suggested that, if the noise continued, rrt could be programmed off.Ts also noted that impedance was within normal limits.No adverse patient effects were reported.Evidence suggests this lead remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17535548
• MDR Text Key: 321373419
• Report Number: MW5142444
• Device Sequence Number: 1
• Product Code: NVN
• 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: 03/08/2021

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: 1388TC
• Patient Sequence Number: 1