MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE DR; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	L301
Medical Device Problem Codes	Pacing Problem (1439); Data Problem (3196); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that programmer interrogation of this pacemaker was unsuccessful, and multiple programmer wands were attempted.Additionally, there was no magnet response, and four different magnets were attempted.There was no change in pacing even with magnet stacked, and the intrinsic rate was in the 50s beats per minute (bpm) range.It was noted that the pacemaker was implanted more than 10 years ago, and it was likely the battery had reached end of life (eol).Additional information received reported that this pacemaker was likely explanted and replaced with a non boston scientific device.No additional adverse patient effects were reported.Product return was requested.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.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 Pulse Generator, Pacemaker (Non-Crt)
• 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: 50216514
• Report Number: 2124215-2026-43093
• Device Sequence Number: 12286679
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: (01)00802526559174(17)180222
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 733926
• 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: 07/28/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 03/08/2016
• 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: 61 YR
• Patient Sex: Female