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

Model Number L111

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581); Under-Sensing (1661); Use of Device Problem (1670)

Patient Problem Bradycardia (1751)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this pacemaker system stored two signal artifact monitor (sam) episodes at the time of the patient's unrelated shoulder surgery.There was oversensed electromagnetic interference (emi) noise on all channels with less than two seconds of pacing inhibition, and the minute ventilation (mv) feature was disabled at that time.Additionally, review of a live electrogram (egm) revealed 4-5 beats of atrial tachycardia below the sensing floor, resulting in right atrial (ra) undersensing.Adjustments to ra sensitivity resolved the observed undersensing, and the mv feature was re-enabled.Technical services (ts) reviewed troubleshooting options and other programming considerations.This pacemaker system remains in service.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO MRI 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: 18749399
• MDR Text Key: 336787785
• Report Number: 2124215-2024-10370
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2024
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 600802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: 77 YR
• Patient Sex: Female