MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? EL ICD VR; Implantable cardioverter defibrillator (ICD)

Model Number	D120
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	09/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate anti-tachycardia pacing (atp) during a sinus tachycardia episode.Upon further review of the episode, boston scientific technical services (ts) discussed the rhythmmatch was not appropriately correlated due to the misalignment of the template with the shock egm.Reprogramming options were discussed.No adverse patient effects were reported.This device remains in service.The complaint device was not returned to boston scientific, therefore, product analysis could not be performed.Additional information was received that this device was suspected of delivering inappropriate atp and electric shocks.Further evaluation by cardiology was recommended.No additional adverse patient effects were reported.This device remains in service.

• Brand Name: MOMENTUM? EL ICD VR
• Common Device Name: Implantable cardioverter defibrillator (ICD)
• 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: 50150248
• Report Number: 2124215-2026-42070
• Device Sequence Number: 13412472
• Product Code: LWS
• UDI-Device Identifier: 00802526587702
• UDI-Public: (01)00802526587702(17)250424
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 04/24/2025
• Device Model Number: D120
• Device Catalogue Number: D120
• Device Lot Number: 217390
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 05/04/2023
• 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: Other
• Patient Age: 45 YR
• Patient Sex: Female