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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G247
Device Problem Defibrillation/Stimulation Problem (1573)
Patient Problem Cardiac Arrest (1762)
Event Date 01/18/2024
Event Type  Injury  
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced cardiac arrest.The patient has concerns that this device did not deliver appropriate electric shocks.Boston scientific technical services (ts) was consulted and referred the patient to the following physician.No additional adverse patient effects were reported.At this time, this device remains in service.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced cardiac arrest.The patient has concerns that this device did not deliver appropriate electric shocks.Boston scientific technical services (ts) was consulted and referred the patient to the following physician.Further information was received that according to the health care professional (hcp), the cardiac arrest episode was suspected to be caused by a drug overdose but given her history, it was uncertain if this was truly a ventricular arrest or not.The device was interrogated and no ventricular tachycardia (vt) episodes were stored.The patient was discharged from the hospital.No additional adverse patient effects were reported.At this time, this device remains in service.
 
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Brand Name
VIGILANT X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY 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 Key18743857
MDR Text Key335792724
Report Number2124215-2024-10160
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589287
UDI-Public00802526589287
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 Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/10/2022
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number238975
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2020
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; Hospitalization; Life Threatening;
Patient Age60 YR
Patient SexFemale
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