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

Model Number G138

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Failure to Read Input Signal (1581); Defective Device (2588); Connection Problem (2900)

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

Event Date 10/04/2023

Event Type  malfunction  

Event Description

It was reported that the right ventricular (rv) lead exhibited high, out-of-range shock impedance measurements of greater than 200 ohms.The left ventricular (lv) lead also exhibited high, out-of-range pace impedance measurements of greater than 3000 ohms.It was believed to possibly be related to a connection issue between the new, recently implanted device and leads.The device and leads remain in service.No adverse patient effects were reported.

Event Description

It was reported that the right ventricular (rv) lead exhibited high, out-of-range shock impedance measurements of greater than 200 ohms.The left ventricular (lv) lead also exhibited high, out-of-range pace impedance measurements of greater than 3000 ohms.It was believed to possibly be related to a connection issue between the new, recently implanted device and leads.The device and leads remain in service.No adverse patient effects were reported.Additional information was received indicating the shock electrogram exhibited low amplitudes.Technical services (ts) was contacted, and ts discussed that the morphology could indicate the rv lead was reversed in the header.It was also noted the lv and rv threshold tests had been failing due to various reasons.The device and leads remain in service.No 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: 17927752
• MDR Text Key: 325602595
• Report Number: 2124215-2023-56748
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2024
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 390289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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 Age: 60 YR
• Patient Sex: Male