MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; IMPLANTABLE DEVICE

Model Number G138

Device Problems High impedance (1291); Connection Problem (2900); Noise, Audible (3273)

Patient Problem Anxiety (2328)

Event Date 08/19/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system was hearing tones from the device.An interrogation was performed and it was noted there was high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead.Lead testing and an x-ray was performed and there was no issues with the lead.Technical services was notified and they discussed possible causes.The physician spoke to the patient and it was decided to replace the device.The patient did experience anxiety.Subsequently, the device was explanted and replaced successfully.The non-boston scientific rv lead remains in service.The device was returned for analysis details.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.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.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system was hearing tones from the device.An interrogation was performed and it was noted there was high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead.Lead testing and an x-ray was performed and there was no issues with the lead.Technical services was notified and they discussed possible causes.The physician spoke to the patient and it was decided to replace the device.The patient did experience anxiety.Subsequently, the device was explanted and replaced successfully.The non-boston scientific rv lead remains in service.The device was returned for analysis details.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 15328326
• MDR Text Key: 298985715
• Report Number: 2124215-2022-33541
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2020
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 381043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male