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

Model Number G125

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Inaccurate Synchronization (1609); High Capture Threshold (3266)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/18/2024

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) oversensed noisy signals on the right ventricular (rv) channel that led to inappropriate anti-tachycardia pacing (atp) and shock therapy.The rv lead is a non-boston scientific product.The second round of atp induced the patient into ventricular fibrillation (vf).A shock converted the patient back to a normal sinus rhythm.However, noisy signals were still present with oversensing.It was noted that there was a total of 29 episodes with the noisy signals since approximately a week before the call.The device exhibited a rise in impedance but remained within range and a rise in capture thresholds.The device was explanted and upgraded to a subcutaneous implantable cardioverter defibrillator (s-icd).No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) oversensed noisy signals on the right ventricular (rv) channel that led to inappropriate anti-tachycardia pacing (atp) and shock therapy.The rv lead is a non-boston scientific product.The second round of atp induced the patient into ventricular fibrillation (vf).A shock converted the patient back to a normal sinus rhythm.However, noisy signals were still present with oversensing.It was noted that there was a total of 29 episodes with the noisy signals since approximately a week before the call.The device exhibited a rise in impedance but remained within range and a rise in capture thresholds.The device was explanted and upgraded to a subcutaneous implantable cardioverter defibrillator (s-icd).No additional adverse patient effects were reported.Additional information received indicates that this device is still implanted, however, it is programmed off.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) oversensed noisy signals on the right ventricular (rv) channel that led to inappropriate anti-tachycardia pacing (atp) and shock therapy.The rv lead is a non-boston scientific product.The second round of atp induced the patient into ventricular fibrillation (vf).A shock converted the patient back to a normal sinus rhythm.However, noisy signals were still present with oversensing.It was noted that there was a total of 29 episodes with the noisy signals since approximately a week before the call.The device exhibited a rise in impedance but remained within range and a rise in capture thresholds.The device was explanted and upgraded to a subcutaneous implantable cardioverter defibrillator (s-icd).No additional adverse patient effects were reported.Additional information received indicates that this device is still implanted, however, it is programmed off.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

• 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: 18652214
• MDR Text Key: 334681451
• Report Number: 2124215-2024-06585
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 157618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female