MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? CRT-D; Cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	G125
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) and the right ventricular (rv) lead experienced a myocardial infarction.This crt-d provided eight shocks that didn't convert the rhythm.Emergency medical services (ems) performed cardiopulmonary resuscitation (cpr) and delivered an external shock to the patient.The field representative (rep) interrogated the device and observed an open circuit alert.Also, the rv lead exhibited a high out of range shock impedance, that was suspected to be greater than 145 ohms.The shock was monophasic and energy was truncated.The patient was transferred to a level one trauma center for a left ventricular assist device (lvad) and possible transplant.Ts discussed that the patient needed a new rv lead since the lead couldn't defibrillate the patient.This crt-d remains in service.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM? CRT-D
• Common Device Name: Cardiac resynchronization therapy defibrillator (CRT-D)
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25830651
• Report Number: 2124215-2026-38105
• Device Sequence Number: 16056714
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: (01)00802526589126(17)240412
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 04/12/2024
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 152690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 04/20/2022
• 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: 63 YR
• Patient Sex: Male