MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE? SR; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	L300
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, indicating the voltage is too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.The pacemaker will remain implanted and the patient will be monitored until radio frequency (rf) telemetry disablement, at which time device replacement should be scheduled.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, indicating the voltage is too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.The pacemaker will remain implanted and the patient will be monitored until radio frequency (rf) telemetry disablement, at which time device replacement should be scheduled.No adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and replaced.No additional adverse patient effects were reported.Product return was requested.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding product return status.At this time, no further information is available.Should additional information become available this report will be updated.This product investigation is still in progress.This report will be updated when product investigation is complete.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding product return status.At this time, no further information is available.Should additional information become available this report will be updated.Correction to h1: report type updated to serious injury.Correction to h6: impact code f26 removed; impact codes f1905 and f08 added to reflect device changeout.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ACCOLADE? SR
• Common Device Name: 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50311728
• Report Number: 2124215-2026-44524
• Device Sequence Number: 10664698
• Product Code: LWP
• UDI-Device Identifier: 00802526559150
• UDI-Public: (01)00802526559150(17)190626
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: 06/26/2019
• Device Model Number: L300
• Device Catalogue Number: L300
• Device Lot Number: 718230
• 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: 08/10/2026
• Supplement Date Received by Manufacturer: 09/04/2026; 09/04/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/25/2026; 09/30/2026
• Date Device Manufactured: 07/24/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female