MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G138

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

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

Event Date 12/04/2020

Event Type  Death  

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, the 'no problem detected' conclusion code was selected based on analysis of the returned product.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.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.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the 'no problem detected' conclusion code was selected based on analysis of the returned product.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.This supplemental is being filed to capture the return date and investigation results.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had an infection.A revision was performed and the crt-d with the left ventricular (lv) lead, right atrial (ra) lead and right ventricular (rv) lead were explanted.No additional adverse patient effects were reported.The device was returned but no problem was detected.Additional information was received which reported that the patient passed away nine days after the explant procedure.

• Brand Name: MOMENTUM X4 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: 11232848
• MDR Text Key: 228782296
• Report Number: 2124215-2021-02037
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2021
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 383206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• 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: 57 YR
• Patient Sex: Male