MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	G126
Medical Device Problem Codes	Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered several rounds of inappropriate anti-tachycardia pacing (atp) and impropriate shocks, therapy was exhausted, due to an episode of atrial fibrillation (af) with rapid ventricular response (rvr).The device displayed an fc1005 code related to an open circuit.It was discovered that gradual shock lead impedance out of range and high thresholds were present, however, these issues were associated directly to the right ventricular (rv) lead, which was capped and replaced.The crtd remains active and in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered several rounds of inappropriate anti-tachycardia pacing (atp) and inappropriate shocks, therapy was exhausted, due to an episode of atrial fibrillation (af) with rapid ventricular response (rvr).The device displayed an fc1005 code related to an open circuit.It was discovered that gradual shock lead impedance out of range and high thresholds were present, however, these issues were associated directly to the right ventricular (rv) lead, which was capped and replaced.The crtd remains active and in service.No adverse patient effects were reported.

• Brand Name: MOMENTUM? CRT-D
• 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 ; 6515826168
• MDR Report Key: 22288450
• Report Number: 2124215-2025-40410
• Device Sequence Number: 8374322
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: (01)00802526589140(17)230812
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 08/12/2023
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 105972
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 09/09/2021
• 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: 77 YR
• Patient Sex: Female