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

Model Number	L300
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated.Technical services (ts) noted based on the age of the device, it may no longer be functional.Ts also recommended trying to place a magnet.It was noted the patient presented to the physician to discuss device replacement.This pacemaker remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated.Technical services (ts) noted based on the age of the device, it may no longer be functional.Ts also recommended trying to place a magnet.It was noted the patient presented to the physician to discuss device replacement.This pacemaker remains in service and no adverse patient effects were reported.Additional information was received and it was reported that this pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.This pacemaker has not been returned for analysis.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated.Technical services (ts) noted based on the age of the device, it may no longer be functional.Ts also recommended trying to place a magnet.It was noted the patient presented to the physician to discuss device replacement.This pacemaker remains in service and no adverse patient effects were reported.Additional information was received and it was reported that this pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.This pacemaker has not been returned for analysis.
Additional Manufacturer Narrative
This device was explanted and was not returned.As such, physical analysis has not been conducted in our laboratory.Based on the available information, and in the absence of a product return, the investigation conclusion code no problem detected was selected.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of difficult to interrogate/telemetry (wand) was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24745171
• Report Number: 2124215-2026-17634
• Device Sequence Number: 12956893
• Product Code: LWP
• 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: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: 04/01/2017
• Device Model Number: L300
• Device Catalogue Number: L300
• Device Lot Number: 701758
• Was Device Available for Evaluation?: No
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 05/26/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/16/2026; 05/28/2026
• Date Device Manufactured: 04/01/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female