MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L131

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Data Problem (3196); High Capture Threshold (3266)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported that the patient noted potential pauses on their iwatch electrocardiogram (ecg) print outs and pacing rates below the lower rate limit.Boston scientific technical services (ts) was consulted to review the data.Upon review of the iwatch data and remote home monitoring data ts noted that the pauses appear to be t-waves or paced beats.One theory discussed was that the iwatch may not be able to visualize the paced beats and in combination of baseline wandering creates longer pacing intervals on the tracing.Ts discussed possible reasons for a device to pace below lower rate limit.During the review of data, ts observed the safety margin on the pacemaker was not programmed appropriately due to high right ventricular (rv) threshold measurements.Further review also observed noise that appeared consistent with minute ventilation sensor oversensing on both the right atrial (ra) and rv channels.Ts suggested further troubleshooting.The pacemaker remains in service and no adverse patient effects were reported.The lead model, serial number and manufacturer information remains unknown at this time.Attempts to obtain this information have been made without success.No additional information is available.If additional information becomes available the report will be updated at that time.

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

• Brand Name: ESSENTIO MRI EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15880415
• MDR Text Key: 307597016
• Report Number: 2124215-2022-49715
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2022
• Device Model Number: L131
• Device Catalogue Number: L131
• Device Lot Number: 911836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1