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

Model Number G125

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Failure to Read Input Signal (1581)

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that boston scientific technical services (ts) was contacted to evaluate stored atrial tachycardia response (atr) episodes that were declared due to over-sensed noise.Upon data review, ts determined that noise was present in all three sensing channels (right atrial, right ventricular, and the shock electrocardiogram).Variable r-wave amplitude measurements were also noted from the right ventricular (rv) lead.Additionally, there was evidence of left ventricular (lv) loss of capture.It was strongly recommended to assess the patient in-clinic, as the implanted leads were 11 years old.Real-time electrocardiogram monitoring with provocative maneuvers and diagnostic imaging were recommended.Further lead monitoring alerts were also provided, should the physician elect to continue with remote monitoring.The involved leads are not boston scientific products.At this time, the system remains implanted and in-service.No adverse patient effects were reported.

• 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: 17971364
• MDR Text Key: 327040187
• Report Number: 2124215-2023-58334
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2023

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: 05/29/2020
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 127985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2023
• Initial Date FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1