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

Model Number G125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) contacted boston scientific indicating that they allegedly had a staphylococcus aureus implant infection.At this time no further information is available, but additional details were requested to the field.No additional adverse patient effects were reported.Evidence suggests that the device remains implanted and in service.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) contacted boston scientific indicating that they allegedly had a staphylococcus aureus implant infection.At this time no further information is available, but additional details were requested to the field.No additional adverse patient effects were reported.Evidence suggests that the device remains implanted and in service.Additional information was received.The device was explanted, and the leads remain implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Follow up report 2: date of event was corrected.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) contacted boston scientific indicating that they allegedly had a staphylococcus aureus implant infection.At this time no further information is available, but additional details were requested to the field.No additional adverse patient effects were reported.Evidence suggests that the device remains implanted and in service.Additional information was received.The device was explanted, and the leads remain implanted.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 18418211
• MDR Text Key: 331588199
• Report Number: 2124215-2023-74328
• 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: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 155563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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; Other; Required Intervention