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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G447
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Thrombosis/Thrombus (4440)
Event Date 07/16/2021
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due infection.It was further reported the patient developed a deep vein thrombosis.No additional adverse patient effects were reported.
 
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Brand Name
RESONATE X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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 Key12541237
MDR Text Key273606136
Report Number2124215-2021-26325
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589539
UDI-Public00802526589539
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/03/2022
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number235597
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age44 YR
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