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

Model Number	L301
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the communicator of this pacemaker displayed a yellow collecting wave.The patient removed their apple watch and power cycled the communicator, a patient-initiated interrogation (pii) was allowed; however, the yellow collecting wave still appeared.Analysis revealed the device and communicator were unable to communicate with one another.Technical services (ts) referred the patient to the clinic to discuss possible radio frequency (rf) settings.No adverse patient effects were reported.This pacemaker remains in service.Additional information was received and it was reported that this pacemaker was explanted and successfully replaced with a non-boston scientific device.No additional adverse patient effects were reported.This pacemaker has not been returned for analysis.
Additional Manufacturer Narrative
This report is being submitted to update the information in sections b5 and h6.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ACCOLADE? DR
• Common Device Name: Implantable 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: 50036635
• Report Number: 2124215-2026-40029
• Device Sequence Number: 13248351
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: (01)00802526559174(17)170902
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 09/02/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 717242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: Not provided; 09/22/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/24/2026; 09/23/2026
• Date Device Manufactured: 09/02/2015
• 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 Sex: Male