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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD DR; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD DR; IMPLANTABLE DEVICE Back to Search Results
Model Number D433
Device Problem Inaccurate Synchronization (1609)
Patient Problem Ventricular Fibrillation (2130)
Event Date 04/16/2023
Event Type  Injury  
Event Description
It was reported that this implantable cardioverter defibrillator (icd) delivered a burst of anti-tachycardia pacing (atp) for ventricular tachycardia.The atp accelerated the rhythm into the programmed ventricular fibrillation zone, after which a 41 joule shock was delivered that converted the rhythm.The icd remains in service and no adverse patient effects were reported.
 
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Brand Name
RESONATE EL ICD DR
Type of Device
IMPLANTABLE DEVICE
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 Key16773173
MDR Text Key313615705
Report Number2124215-2023-18744
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P960040/S385
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
Report Date 04/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberD433
Device Catalogue NumberD433
Device Lot Number624329
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2022
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) Required Intervention;
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