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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 (CRT-D)
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BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Back to Search Results
Model Number G247
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Endocarditis (1834)
Event Date 09/21/2022
Event Type  Injury  
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was explanted due to suspected endocarditis.No additional adverse patient effects were reported.The device is expected to return for analysis.
 
Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.The allegation could not be confirmed.However, endocarditis is a known inherent risk of the use of the device.
 
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was explanted due to suspected endocarditis.No additional adverse patient effects were reported.The device is expected to return for analysis.Subsequently, the device was returned for analysis.
 
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Brand Name
VIGILANT X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 Key15491365
MDR Text Key300645421
Report Number2124215-2022-38106
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/08/2021
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number222275
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2019
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;
Patient Age66 YR
Patient SexMale
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