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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION RESONATE HF ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number D533
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Electric Shock (2554)
Event Date 02/18/2023
Event Type  Injury  
Event Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate electric shocks and anti-tachycardia pacing (atp) for atrial driven events.No additional adverse patient effects were reported.At this time, this device remains in service.
 
Event Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate electric shocks and anti-tachycardia pacing (atp) for atrial driven events.Additional information was received that during an ablation procedure, this device recorded a signal artifact monitor (sam) episode that resulted in the minute ventilation (mv) feature being disabled.Boston scientific technical services (ts) was consulted and discussed device features and optimization.No additional adverse patient effects were reported.At this time, this device remains in service.
 
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Brand Name
RESONATE HF ICD DR
Type of Device
IMPLANTABLE CARDIOVERTER 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 Key16819887
MDR Text Key314052787
Report Number2124215-2023-20172
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526588310
UDI-Public00802526588310
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960040/S385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/23/2023
Device Model NumberD533
Device Catalogue NumberD533
Device Lot Number606766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2021
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) Other;
Patient Age67 YR
Patient SexMale
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