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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G447
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 02/20/2024
Event Type  malfunction  
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) diverted a shock due to the patient rhythm returning to sinus rhythm.The second shock was not diverted despite the patient rhythm returning to sinus rhythm in the same episode.The plan is to have the patient come into the clinic for a follow-up.No additional adverse patient effects were reported.The device remains in-service.
 
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Brand Name
RESONATE 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 Key18797241
MDR Text Key337619041
Report Number2124215-2024-11884
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number298675
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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