MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO? EL DR; Implantable Pacemaker

Model Number	L121
Medical Device Problem Codes	Premature Discharge of Battery (1057); Nonstandard Device (1420); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction

• Brand Name: ESSENTIO? EL DR
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50872286
• Report Number: 2124215-2026-50724
• Device Sequence Number: 18820334
• Product Code: LWP
• UDI-Device Identifier: 00802526558986
• UDI-Public: (01)00802526558986(17)171020
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/20/2017
• Device Model Number: L121
• Device Catalogue Number: L121
• Device Lot Number: 706854
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2015
• 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
• Patient Sex: Male