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

Model Number L111

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

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

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned and analysis will be performed, a supplemental report will be filed if there is any further relevant information from that review.

Event Description

It was reported that this implantable pacemaker longevity dropped from three years to less than three months in just one year and a month.A request was made to have data from this device analyzed.Data analysis confirmed device power consumption is increasing in a gradual fashion.Device replacement was recommended or have the device battery statis re-evaluated within 90 days.Additional information received indicating that this pacemaker was explanted due to advisory/recall.Furthermore, a new device was implanted.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO MRI DR
• Type of Device: IMPLANTABLE PACEMAKER DEVICE
• 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: 19141961
• MDR Text Key: 340562837
• Report Number: 2124215-2024-23835
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/08/2019
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 326658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2017
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male