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

Model Number	L100
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable pacemaker was explanted due to non-specific product performance issue.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable pacemaker was explanted due to non-specific product performance issue.No additional adverse patient effects were reported.Subsequently, additional information was received indicating that the whole system was explanted due to lead measurements trending upwards.No additional information was provided.

• Brand Name: ESSENTIO SR
• Common Device Name: 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: 20922091
• Report Number: 2124215-2024-78927
• Device Sequence Number: 5093048
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: 00802526558900
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/10/2022
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 729698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 12/31/2024
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male