MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G124

Device Problems Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581); Under-Sensing (1661); Device Sensing Problem (2917); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited right atrial (ra) undersensing and low p-wave amplitude measurements.Additionally, suboptimal right ventricular (rv) impedance and high pacing threshold measurements were observed; therefore, the system was programmed to left ventricular (lv) pacing only.Boston scientific technical services (ts) reviewed data from the device and confirmed that undersensing resulted in backup pacing and indicated that the cause of undersensing is mostly the low amplitude of the atrial signals.Ts also found several atrial tachy response (atr) events caused by potential farfield oversensing which led to inappropriate mode switching.Reprogramming options and lead revision or replacement were recommended.At this time, no further information is available.Of note, the rv lead is a non-boston scientific product.The device remains in service and no adverse patient effects have been reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18818666
• MDR Text Key: 336685313
• Report Number: 2124215-2024-12652
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2020
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 492150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1