MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE? SR; Pacemaker

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	09/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, which states that the voltage is too low for projected remaining capacity.It was reported that a request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.Device replacement was recommended.This device was explanted and was not returned for analysis.Other than the surgical procedure, no additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Analysis of the device confirmed that a low voltage alert, code 1003, was recorded and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high battery impedance, which put this device at risk of experiencing transient voltage decreases (and associated resets) during telemetry or other normal, higher-power operations.When the device detects an elevated battery impedance, a code 1003 is displayed to alert users that a high battery impedance condition exists.Boston scientific has issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to exhibit this behavior.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, which states that the voltage is too low for projected remaining capacity.It was reported that a request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.Device replacement was recommended.This device was explanted and was not returned for analysis.Other than the surgical procedure, no additional adverse patient effects were reported.

• Brand Name: ACCOLADE? SR
• Common Device Name: 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: 23349681
• Report Number: 2124215-2025-75165
• Device Sequence Number: 15442994
• Product Code: LWP
• UDI-Device Identifier: 00802526559150
• UDI-Public: (01)00802526559150(17)200104
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2026

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: 01/04/2020
• Device Model Number: L300
• Device Catalogue Number: L300
• Device Lot Number: 720848
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 03/02/2026; 08/25/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 03/03/2026; 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2124215-03/18/26-001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male