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

Model Number	L300
Medical Device Problem Codes	High impedance (1291); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker displayed a red call doctor alert.Additionally, it was found that this device and the communicator for the patient could not establish a connection.At this time, the reason for the alert remains unknown.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this pacemaker displayed a red call doctor alert.Additionally, it was found that this device and the communicator for the patient could not establish a connection.At this time, the reason for the alert remains unknown.This device remains in service.No adverse patient effects were reported.Additional information was obtained stating this pacemaker system exhibited a lead safety switch (lss) due to pacing impedance measurements greater than 3000 ohms on the right ventricular (rv) lead.It was noted that the rv lead is not a boston scientific product.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was added to the following fields: b5: describe event or problem field.F10: device codes.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: 24533658
• Report Number: 2124215-2026-12624
• Device Sequence Number: 10393625
• Product Code: LWP
• UDI-Device Identifier: 00802526559150
• UDI-Public: (01)00802526559150(17)190627
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2026

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: 06/27/2019
• Device Model Number: L300
• Device Catalogue Number: L300
• Device Lot Number: 718259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 05/20/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/09/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2017
• 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
• Patient Age: 75 YR
• Patient Sex: Male