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); Over-Sensing (1438); Pacing Problem (1439)

Patient Problems Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this recently implanted cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise with oversensing and pacing inhibition.Technical services (ts) reviewed troubleshooting options and possible causes.This crt-d remains in service.No adverse patient effects were reported.

Event Description

It was reported that this this recently implanted cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise with oversensing and pacing inhibition.Technical services (ts) reviewed troubleshooting options and possible causes.This crt-d remains in service.No adverse patient effects were reported.Additional information received reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) system was admitted to the hospital and underwent further evaluation due to experiencing syncopal episodes.As a result, the physician was considering possible revision.The previously reported oversensing was not reproducible with isometrics, however no pacing inhibition was observed once biventricular pacing was programmed on.Additionally, all lead measurements were within normal range.The patient was kept under observation for an additional night before getting discharged from the hospital.This crt-d system remains in service and will continue to be monitored at this time.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: 18161852
• MDR Text Key: 328436836
• Report Number: 2124215-2023-65051
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2024
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 152716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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 Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male