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

Model Number	L310
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a clinic visit, the health care professional (hcp) reported being unable to read this pacemaker device data on the programmer.The hcp called technical services (ts) for troubleshooting assistance.Ts verified the correct programmer was in use and walked the hcp through troubleshooting and rebooting efforts.The troubleshooting efforts were unsuccessful due to programmer was unable to interrogate the device.Ts discussed possible causes and advised the hcp to contact the local field representative for further troubleshooting assistance.No adverse patient effects were reported.At this time, the pacemaker and programmer remain in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: ACCOLADE? MRI 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 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: 50820617
• Report Number: 2124215-2026-49993
• Device Sequence Number: 18803577
• Product Code: LWP
• UDI-Device Identifier: 00802526559204
• UDI-Public: (01)00802526559204(17)240627
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 06/27/2024
• Device Model Number: L310
• Device Catalogue Number: L310
• Device Lot Number: 866711
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 07/06/2022
• 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: 78 YR
• Patient Sex: Female