MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G138

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Delayed Charge Time (2586); Battery Problem (2885)

Patient Problems Shock from Patient Lead(s) (3162); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low shock impedance out of range, measuring 5 ohms.No noise or artifacts were observed, and it was confirmed that the shock impedance trend of the implanted right ventricular (rv) lead is stable.Technical services (ts) provided guidance and recommended a patient follow up.At this time, no further information is available.No adverse patient effects were reported.The device remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low shock impedance out of range, measuring 5 ohms.No noise or artifacts were observed, and it was confirmed that the shock impedance trend of the implanted right ventricular (rv) lead is stable.Technical services (ts) provided guidance and recommended a patient follow up.At this time, no further information is available.No adverse patient effects were reported.The device remains in service.Additional information was received.A new alert for low shock impedance out of range measurements was displayed on the remote monitoring system.Ts indicated that this condition needs further investigation to check the integrity of the rv lead.Further troubleshooting steps were provided, including x-ray imaging to rule out lead impairment.Remote monitoring, closer follow-ups, and device programming options were also discussed as part of the potential plan for this patient.An in-clinic follow up will be scheduled to evaluate the patient and device.The device remains in service and no adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low shock impedance out of range, measuring 5 ohms.No noise or artifacts were observed, and it was confirmed that the shock impedance trend of the implanted right ventricular (rv) lead is stable.Technical services (ts) provided guidance and recommended a patient follow up.At this time, no further information is available.No adverse patient effects were reported.The device remains in service.Additional information was received.A new alert for low shock impedance out of range measurements was displayed on the remote monitoring system.Ts indicated that this condition needs further investigation to check the integrity of the rv lead.Further troubleshooting steps were provided, including x-ray imaging to rule out lead impairment.Remote monitoring, closer follow-ups, and device programming options were also discussed as part of the potential plan for this patient.An in-clinic follow up will be scheduled to evaluate the patient and device.The device remains in service and no adverse patient effects were reported.Additional information provided from the field indicated that this patient attended the hospital and upon interrogation, it was found that the device had delivered a shock for what appeared to be an atrial driven rhythm.Additionally, code 1004 indicative of a short circuit condition and code 1007 due to capacitor charge time exceeding limitations were observed along with noisy signals on the rv pace and shock channels.Consequently, surgical intervention was performed, and this device was explanted and replaced, and the rv lead was replaced and abandoned in the patient.No additional adverse patient effects were reported.The explanted device is expected to be returned for analysis.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low shock impedance out of range, measuring 5 ohms.No noise or artifacts were observed, and it was confirmed that the shock impedance trend of the implanted right ventricular (rv) lead is stable.Technical services (ts) provided guidance and recommended a patient follow up.At this time, no further information is available.No adverse patient effects were reported.The device remains in service.Additional information was received.A new alert for low shock impedance out of range measurements was displayed on the remote monitoring system.Ts indicated that this condition needs further investigation to check the integrity of the rv lead.Further troubleshooting steps were provided, including x-ray imaging to rule out lead impairment.Remote monitoring, closer follow-ups, and device programming options were also discussed as part of the potential plan for this patient.An in-clinic follow up will be scheduled to evaluate the patient and device.The device remains in service and no adverse patient effects were reported.Additional information provided from the field indicated that this patient attended the hospital and upon interrogation, it was found that the device had delivered a shock for what appeared to be an atrial driven rhythm.Additionally, code 1004 indicative of a short circuit condition and code 1007 due to capacitor charge time exceeding limitations were observed along with noisy signals on the rv pace and shock channels.The device was also found to be in the end of life (eol) status, so surgical intervention was performed, and it was explanted and replaced, and the rv lead was replaced and abandoned in the patient.No additional adverse patient effects were reported.The explanted device is expected to be returned for analysis.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.

• Brand Name: MOMENTUM X4 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: 17667013
• MDR Text Key: 322532736
• Report Number: 2124215-2023-47334
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 387281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/22/2023; 02/29/2024; 02/29/2024
• Supplement Dates FDA Received: 10/05/2023; 03/04/2024; 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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