MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO MRI DR; IMPLANTABLE PACEMAKER

Model Number L111

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the battery of this implantable pacemaker device was suspected to be depleting prematurely.This device was implanted for approximately a year now and the battery shows five years remaining.Boston scientific technical services (ts) noted that there was a slight increase in power consumption and the patient was in chronic atrial fibrillation (af).Ts also discussed the impact of high-rate atrial sensing on battery longevity, and that device is of standard longevity.Device reprogramming was recommended, and the patient will continue to be monitored.This device remains in service.No adverse patient effects were reported.

• Brand Name: ESSENTIO MRI DR
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 19134559
• MDR Text Key: 340829157
• Report Number: 2124215-2024-23619
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558962
• UDI-Public: 00802526558962
• 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: 04/18/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 665164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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: 86 YR
• Patient Sex: Female