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

Model Number	L301
Medical Device Problem Codes	Extracardiac stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the emergency room (er) due to feeling intermittent pocket stimulation, with a heart rate in the 70's.A magnet was applied to the pacemaker and no response was elicited.After discussion with technical services, and performing a device interrogation, it was determined that the device was in safety mode.The device was immediately replaced and received for analysis.

• Brand Name: ACCOLADE DR
• Common Device Name: Implantable Device
• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50129049
• Report Number: 2124215-2026-41666
• Device Sequence Number: 10528189
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: (01)00802526559174(17)180222
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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: 02/22/2018
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 734046
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2016
• 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: 45 YR
• Patient Sex: Female