MAUDE Adverse Event Report: ST. JUDE MEDICAL DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 1258T

Device Problems Signal Artifact/Noise (1036); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the remote home monitor showed out of range impedance measurements on the right atrial (ra), right ventricular (rv) and left ventricular (lv) channels.There was also two signal artifact monitoring events from the same day as the out of range impedance measurements.Upon review, boston scientific technical services (ts) noted that there was noise on several episodes and it appeared to be possible minute ventilation signal.Ts notes that the lead impedance trends showed stable impedances for the ra and rv leads in the 300 to 400 ohm range that then elevated to 1000 to 1200 ohms.The impedance then increases to great than 3000 ohms.The lv lead showed comparable patterns in lead impedance trend without the decrease to less than 200 ohms.Ts discussed possible reasons this could occur and suggested following up with the patient.The cardiac resynchronization therapy pacemaker (crt-p) 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: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17523863
• MDR Text Key: 321384738
• Report Number: MW5130811
• Device Sequence Number: 1
• Product Code: OJX
• 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: 08/19/2020

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: 1258T
• Patient Sequence Number: 1