MAUDE Adverse Event Report: ESSENTIO MRI DR; IMPLANTABLE PACEMAKER

Model Number L111

Device Problems Failure to Capture (1081); Under-Sensing (1661); Device Sensing Problem (2917); High Capture Threshold (3266)

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

Event Date 12/23/2023

Event Type  malfunction  

Event Description

It was reported that this pacemaker's right atrial autothreshold (raat) test was thrown off by premature ventricular contractions (pvcs).Technical services (ts) reviewed and stated that it was odd that the raat would behave this way with pvcs.The health care professional (hcp) decided to disable the raat and right ventricular autothreshold (rvat) test features.It was noted that the rv channel exhibited loss of capture (loc) at high capture thresholds during the test.Additionally, there was undersensing in atrial tachy response (atr) episodes on the right atrial (ra) channel.The hcp reprogrammed the sensitivity of the ra channel.The device remains in use.No adverse patient effects were reported.

• Brand Name: ESSENTIO MRI DR
• Type of Device: IMPLANTABLE PACEMAKER
• MDR Report Key: 18714393
• MDR Text Key: 336526141
• Report Number: 2124215-2024-09087
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 711396
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Sex: Female