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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEFIBRILLATOR Back to Search Results
Model Number G447
Device Problem Failure to Convert Rhythm (1540)
Patient Problems Ventricular Fibrillation (2130); Electric Shock (2554)
Event Date 02/08/2023
Event Type  Injury  
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) arrived at the emergency room (er) due to having failed to convert the rhythm of this patient intrinsic ventricular fibrillation after several shocks.A commanded shock was performed; however, this did not convert either.An external defibrillation was given which ended the episode.It was decided to add a new lead and to explant and replace this device.After this a defibrillation threshold test (dft) was given in order to evaluate the new system.No further adverse patient effects were reported.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) arrived at the emergency room (er) due to having failed to convert the rhythm of this patient intrinsic ventricular fibrillation after several shocks.A commanded shock was performed; however, this did not convert either.An external defibrillation was given which ended the episode.It was decided to add a new lead and to explant and replace this device.After this a defibrillation threshold test (dft) was given in order to evaluate the new system.No further adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
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Brand Name
RESONATE X4 CRT-D
Type of Device
IMPLANTABLE 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 Key17064758
MDR Text Key316568403
Report Number2124215-2023-28542
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 Other
Type of Report Initial,Followup
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/04/2021
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number213466
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received11/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2019
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; Life Threatening; Required Intervention;
Patient Age38 YR
Patient SexMale
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