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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G124
Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 04/08/2024
Event Type  malfunction  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that alerts were generated for this system for cardiac resynchronization therapy pacing of less than 80%, anti-tachycardia pacing (atp) therapy delivered to convert an arrhythmia and ventricular shock therapy delivered to convert an arrhythmia.Episode review identified the therapy was potentially inappropriate for an atrial arrhythmia with rapid ventricular response (rvr).The rhythmmatch score was greater than 97%; however, the v>a criteria was met.The device was programmed to vvir with atrial sensing off and atrial tachycardia discrimination remains on.The clinical observations were documented, and the system remains in service.No adverse patient effects were reported.
 
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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 Key19213659
MDR Text Key341396736
Report Number2124215-2024-26096
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/07/2023
Device Model NumberG124
Device Catalogue NumberG124
Device Lot Number506961
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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