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

Model Number G125

Device Problem Defective Device (2588)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

Event Description

It was reported that patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced phrenic nerve stimulation.The device was surgically explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced phrenic nerve stimulation.The device was surgically explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Detailed analysis did not nonspecific product performance allegation as baseline testing completed on the device found no failing conditions.All testing that was completed on the device passed or was not applicable, therefore no problem was detected.Also, muscle stimulation allegation could not be confirmed by lab analysis moreover, known inherent risk was based on the field report of muscle stimulation.Muscle stimulation is a known medical risk for implanted pulse generator systems (pacemakers, defibrillators, rhythm therapy devices and associated cardiac leads).This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• 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
• 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: 16862419
• MDR Text Key: 314484375
• Report Number: 2124215-2023-21501
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2022
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 138117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female