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

Model Number G124

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); High impedance (1291); Battery Problem (2885); Connection Problem (2900); High Capture Threshold (3266)

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

Event Date 08/08/2023

Event Type  Injury  

Event Description

It was reported that this device exhibited left ventricular (lv) pace impedance measurements of greater than 3,000 ohms and lv and right ventricular (rv) loss of capture (loc).This patient was not pacemaker dependent at that time.Technical services (ts) recommended to consider a chest x ray.The x ray was revealed a small gap between the terminal boot and the ring connector block in the lv port which ts discussed could be evidence of a marginally inserted terminal pin.The lv threshold output measurements were high, resulting in a decrease in this devices battery longevity.This patient has comorbidities specifically esophageal cancer and their life expectancy may not exceed the device longevity.The field representative will leave it up to the physician as to the future plan for this patient regarding possible programming changes or surgical intervention.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this device exhibited left ventricular (lv) pace impedance measurements of greater than 3,000 ohms and lv and right ventricular (rv) loss of capture (loc).This patient was not pacemaker dependent at that time.Technical services (ts) recommended to consider a chest x ray.The x ray was revealed a small gap between the terminal boot and the ring connector block in the lv port which ts discussed could be evidence of a marginally inserted terminal pin.The lv threshold output measurements were high, resulting in a decrease in this devices battery longevity.This patient has comorbidities specifically esophageal cancer and their life expectancy may not exceed the device longevity.The field representative will leave it up to the physician as to the future plan for this patient regarding possible programming changes or surgical intervention.This device remains in service.No adverse patient effects were reported.Additional information was received that this patient went for a revision procedure in which the pocket was opened, and the lv lead was pulled out, cleaned up and reinserted the pin.The lv lead was noted to be working well again and it was confirmed to be a set screw issue.This device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: MOMENTUM 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: 18527960
• MDR Text Key: 333500139
• Report Number: 2124215-2024-02239
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 514068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Male