MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE? MRI EL DR; pacemaker

Model Number	L331
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this pacemaker was being seen in the clinic.While in the clinic, a message was displayed indicating that radio frequency (rf) telemetry was disabled.Technical services (ts) reviewed the data and discussed the device had the most recent software and suspected that when the software was downloaded, the battery voltage was low enough that it disabled rf in the device.A clinician confirmed rf was disabled.Ts recommended device replacement.No adverse patient effects were reported.This pacemaker remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ACCOLADE? MRI EL DR
• 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: 50931991
• Report Number: 2124215-2026-51641
• Device Sequence Number: 16133727
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: (01)00802526559266(17)190817
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 08/17/2019
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 764677
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 08/30/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male