MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G138

Device Problems Failure to Capture (1081); High impedance (1291); Connection Problem (2900)

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

Event Date 05/10/2023

Event Type  Injury  

Event Description

It was reported that this patient was upgraded from an implantable cardioverter defibrillator (icd) to a cardiac resynchronization therapy defibrillator (crt-d) which required the addition of a left ventricular (lv) lead.The implant procedure was successful and normal measurements were confirmed the following morning and the patient was discharged.Subsequent data from remote monitoring revealed suspected loss of capture on the lv channel.Therefore, the patient was brought back to the hospital for an x-ray and re-testing.Pacing impedance measurements were greater than 3000 ohms and x-ray revealed the lv lead was not fully inserted into the device header.The pocket was re-opened, and this lead was re-inserted into the header.The set screw was tightened, and successful lv lead to device connection was confirmed with a tug test.Acceptable lead measurements were obtained.During the procedure, damage to the df1 and high voltage (hv) distal and proximal pin connectors was observed on the right ventricular (rv) lead.The hv segments were bent at a right angle where the pin connectors connect to the device.Normal shock impedance measurements were confirmed.The physician repaired the distal hv insulation instead of replacing the lead as there was scar tissue and multiple leads in the vein.Shock impedance in right ventricular (rv) coil to can configuration was 100 ohms following the repair.The procedure was completed without further incident.No additional adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient was upgraded from an implantable cardioverter defibrillator (icd) to a cardiac resynchronization therapy defibrillator (crt-d) which required the addition of a left ventricular (lv) lead.The implant procedure was successful and normal measurements were confirmed the following morning and the patient was discharged.Subsequent data from remote monitoring revealed suspected loss of capture on the lv channel.Therefore, the patient was brought back to the hospital for an x-ray and re-testing.Pacing impedance measurements were greater than 3000 ohms and x-ray revealed the lv lead was not fully inserted into the device header.The pocket was re-opened, and this lead was re-inserted into the header.The set screw was tightened, and successful lv lead to device connection was confirmed with a tug test.Acceptable lead measurements were obtained.During the procedure, damage to the df1 and high voltage (hv) distal and proximal pin connectors was observed on the right ventricular (rv) lead.The hv segments were bent at a right angle where the pin connectors connect to the device.Normal shock impedance measurements were confirmed.The physician repaired the distal hv insulation instead of replacing the lead as there was scar tissue and multiple leads in the vein.Shock impedance in right ventricular (rv) coil to can configuration was 100 ohms following the repair.The procedure was completed without further incident.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 noted evidence indicating difficulty may have been encountered fully inserting an is-1/df-1 lead into the header of this device resulting in the reported clinical observations.Please refer to the description for more information regarding the specific circumstances of this event.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: MOMENTUM X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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: 16944854
• MDR Text Key: 315357430
• Report Number: 2124215-2023-24479
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 388405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male