MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; IMPLANTABLE DEFIBRILLATOR

Model Number G125

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

Patient Problems Electric Shock (2554); Asystole (4442)

Event Date 12/02/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing and pacing inhibition of over two seconds on the right ventricular channel.Reprograming and a potential defibrillation threshold (dft) test was discussed.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields:.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing and pacing inhibition of over two seconds on the right ventricular channel.Reprograming and a potential defibrillation threshold (dft) test was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that a dft was performed.Reprograming of the device and potential lead revision were discussed.

• Brand Name: MOMENTUM CRT-D
• Type of Device: IMPLANTABLE 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: 16375102
• MDR Text Key: 309552143
• Report Number: 2124215-2023-06651
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: 00802526589126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2022
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 139231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male