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

Model Number G125

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.There were no additional adverse patient effects reported.The crt-d was explanted.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that this explanted product was returned but no analysis was performed as reported allegations of infection were known inherent risk of device.This supplemental is being filed to capture the return date and investigation results.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.There were no additional adverse patient effects reported.The crt-d was explanted.

• 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
• MDR Report Key: 11227911
• MDR Text Key: 228617521
• Report Number: 2124215-2021-01729
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: 00802526589126
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/21/2022
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 140947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR