MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? EL ICD VR; Implantable device

Model Number	D120
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range pacing impedances above 3000 ohms on the right ventricular (rv) channel.It was noted that the associated rv lead is a non-boston scientific product, which was surgically abandoned.This icd was explanted and successfully replaced with a cardiac resynchronization therapy defibrillator (crt-d) device.No additional adverse patient effects were reported.This icd was retained by the healthcare facility and therefore is not expected to be returned for analysis.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: MOMENTUM? EL ICD VR
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50613471
• Report Number: 2124215-2026-47324
• Device Sequence Number: 10742577
• Product Code: LWS
• UDI-Device Identifier: 00802526587702
• UDI-Public: (01)00802526587702(17)210926
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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: 09/26/2021
• Device Model Number: D120
• Device Catalogue Number: D120
• Device Lot Number: 206004
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/07/2026
• Date Device Manufactured: 10/25/2019
• 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 Age: 73 YR
• Patient Sex: Male