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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION RESONATE CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G424
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Electric Shock (2554)
Event Date 10/18/2023
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded inappropriate shocks due to supraventricular tachycardia (svt).Boston scientific technical services indicated that the reason of therapy being delivered was exceeding atrial rate greater than atrial fibrillation rate.Technical services provided options such as controlling the patients medication, and programming suggestions.No adverse patient effects were reported.This device remains in-service.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded inappropriate shocks due to supraventricular tachycardia (svt).Boston scientific technical services indicated that the reason of therapy being delivered was exceeding atrial rate greater than atrial fibrillation rate.Technical services provided options such as controlling the patients medication, and programming suggestions.No adverse patient effects were reported.This device remains in-service.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.
 
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Brand Name
RESONATE 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 Key18038243
MDR Text Key326955262
Report Number2124215-2023-60603
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeSP
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,Followup
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberG424
Device Catalogue NumberG424
Device Lot Number510561
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/18/2023
Initial Date FDA Received10/31/2023
Supplement Dates Manufacturer Received11/20/2023
Supplement Dates FDA Received12/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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