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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 Problems High impedance (1291); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661); High Capture Threshold (3266)
Patient Problem Electric Shock (2554)
Event Date 12/11/2023
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 this system displayed alerts for delivery of anti-tachycardia pacing (atp) and shock therapy delivered to convert an arrhythmia.The shock successfully converted the arrhythmia.The rate was 197bpm and was detected in the ventricular tachycardia (vt) zone; however, an atrial arrhythmia was in progress and atrial undersensing was observed.Review of the stored data identified an episode of non-sustained vt with atrial undersensing.Additionally, the data showed an increase in left ventricular (lv) pacing impedance.All other lead measurements were stable.Atrial sensitivity was programmed to automatic gain control (agc) 0.6mv.Additional alerts were subsequently reported for atrial arrhythmia burden (aab) of at least 6.0 hours in a 24-hour period and atrial automatic threshold detected as greater than programmed amplitude or suspended.Further system review was recommended.The system remains implanted.No adverse patient effects were reported.
 
Event Description
It was reported that this system displayed alerts for delivery of anti-tachycardia pacing (atp) and shock therapy delivered to convert an arrhythmia.The shock successfully converted the arrhythmia.The rate was 197bpm and was detected in the ventricular tachycardia (vt) zone; however, an atrial arrhythmia was in progress and atrial undersensing was observed.Review of the stored data identified an episode of non-sustained vt with atrial undersensing.Additionally, the data showed an increase in left ventricular (lv) pacing impedance.All other lead measurements were stable.Atrial sensitivity was programmed to automatic gain control (agc) 0.6mv.Additional alerts were subsequently reported for atrial arrhythmia burden (aab) of at least 6.0 hours in a 24-hour period and atrial automatic threshold detected as greater than programmed amplitude or suspended.Further system review was recommended.The system remains implanted.No adverse patient effects were reported.This supplemental report is being submitted to provide the patient identifier information.
 
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.
 
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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 Key18463601
MDR Text Key332295953
Report Number2124215-2023-75469
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,Followup
Report Date 01/12/2024
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 Model NumberG447
Device Catalogue NumberG447
Device Lot Number312895
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received01/08/2024
Supplement Dates Manufacturer Received01/08/2024
Supplement Dates FDA Received01/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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