MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G124

Device Problem Defective Device (2588)

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

Event Date 02/15/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to unknown reasons.No additional information is available at the moment.No additional adverse patient effects were reported.

Manufacturer Narrative

This event no longer meets complaint criteria, the system was explanted to give the patient an mdr compatible system, consider this a therapy upgrade.Does not meet complaint criteria.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to unknown reasons.No additional information is available at the moment.No additional adverse patient effects were reported.Additional information was obtained, the device was explanted to give the patient an mdr compatible system.

• Brand Name: MOMENTUM CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 16452348
• MDR Text Key: 310337379
• Report Number: 2124215-2023-09276
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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: 513857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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: 80 YR
• Patient Sex: Male