MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM EL ICD VR; Implantable Cardioverter Defibrillator

Model Number	D120
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered one inappropriate shock therapy and anti-tachycardia pacing (atp) due to possible rapid ventricular response (rvr).This device remains in service.No adverse patient effects were reported.Additional information was received which indicated that, this icd delivered another inappropriate shock and anti-tachycardia pacing (atp) due to possible rapid ventricular response (rvr) due to atrial arrhythmia.Therapy did not convert rhythm.There were not out of range measurements.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM EL ICD VR
• Common Device Name: Implantable Cardioverter Defibrillator
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50012564
• Report Number: 2124215-2026-39880
• Device Sequence Number: 13390462
• Product Code: LWS
• UDI-Device Identifier: 00802526587702
• UDI-Public: 00802526587702
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: 11/06/2022
• Device Model Number: D120
• Device Catalogue Number: D120
• Device Lot Number: 208622
• 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: 07/17/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 11/26/2020
• 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: 69 YR
• Patient Sex: Male