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

Model Number G125

Device Problems Failure to Capture (1081); Failure to Convert Rhythm (1540); Under-Sensing (1661)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Electric Shock (2554)

Event Date 07/02/2020

Event Type  Injury  

Event Description

It was reported that this patient was admitted to the hospital intensive care unit (icu) due to cardiac arrest.The patient was noted to have a very low ejection fraction (ef).A review of data from the patients implanted cardiac resynchronization therapy defibrillator (crt-d) device indicated that the device had delivered twelve (12) total shocks across several ventricular tachycardia (vt) episodes on that day.The patients rhythm was noted to be polymorphic vt that progressed into fine ventricular fibrillation (vf).The shock therapy was noted to be appropriate but there were multiple shocks with unsuccessful arrhythmia conversion and in the first episode, therapy was exhausted.Boston scientific technical services (ts) indicated that following the first episode, the patients arrhythmia must have converted on its own as there were subsequent episodes with additional shock therapy provided and successful arrhythmia conversion.Ts noted however that there was questionable capture observed at the end of the second episode in addition to some undersensing observed of the fine vf signals.The presenting electrogram (egm) from that same day showed intrinsic atrial sensed beats and bi-ventricular pacing beats.The device remains in-service.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10616079
• MDR Text Key: 209541976
• Report Number: 2124215-2020-16726
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2022
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 137978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 46 YR