MAUDE Adverse Event Report: ST. JUDE MEDICAL RV LEAD, LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1222T 1038T

Device Problems Electromagnetic Interference (1194); Over-Sensing (1438); Ambient Noise Problem (2877)

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

Event Type  malfunction  

Event Description

It was reported that this pacemaker device has exhibited noise and oversensing intermittently on both the right atrial (ra) and right ventricular (rv) leads since the device was implanted in 2014.The ra and rv leads are not boston scientific products.The ra and rv lead impedance trends were noted to be stable with no out of range measurements.The rv lead threshold has been typically around 1 volt but more recently has shown some measurements in the 2.8 to 3 volt range, which boston scientific technical services (ts) indicated may be an indication of a lead issue.The patient is indicated to receive device pacing therapy very infrequently and the ra and rv leads were noted to be in service since 1992.Ts also indicated that some of the stored episodes appear to be noise due to external electromagnetic interference (emi) and provided guidance to the healthcare provider (hcp) to inquire about the patient's work and to perform arm movement and isometric testing to see if noise can be reproduced.The products remain in-service.No patient symptoms or 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: RV LEAD, LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17525720
• MDR Text Key: 321364702
• Report Number: MW5132661
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1222T 1038T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1